CDC continues to study the spread and effects of the novel coronavirus across the United States. We now know from recent studies that a significant portion of individuals with coronavirus lack symptoms (“asymptomatic”) and that even those who eventually develop symptoms (“pre-symptomatic”) can transmit the virus to others before showing symptoms. This means that the virus can spread between people interacting in close proximity—for example, speaking, coughing, or sneezing—even if those people are not exhibiting symptoms. In light of this new evidence, CDC recommends wearing cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission.
The level of protection you require is based on personal preference. For our products the levels of protective starts at least to most protection:
You see many people wearing washable cotton masks. These are not certified to offer protection against air-borne pathogens. However, they offer protection better than nothing. We recommend using certified protective masks that offer a certifiable level of protection. Our masks offer protection from ≥60-≥99%
Face Mask Levels
Respiratory protection in the form of disposable dust masks come in three respirator ratings: FFP1, FFP2, and FFP3 – FFP stands for “Filtering Face Piece” and the number denotes the level of protection.
Our inventory of products are rated on the American Society for Testing and Materials (ASTM). The three levels consist of:
ASTM Level 1 – Low fluid resistance – FFP 1: disposable civilian masks – 3-ply
ASTM Level 2 – Moderate fluid resistance – FFP 2: disposable medical/surgical – 3-ply; KN95 and N95 masks – 4 or 5-ply
ASTM Level 3 – High fluid resistance – FFP3 N99 and FFPN100 masks – 5-ply
Level 1 masks (ASTM low barrier) are designed for procedures with low amounts of blood, fluid, spray and/or aerosol exposure. Common clinical examples include patient exams, operatory cleaning, impressions, lab trimming and orthodontic work. Level 1 masks are fiberglass/latex free and made with a form-fitting pliable nose and chin band.
Level 2 masks (ASTM moderate barrier) are ideal for procedures where moderate to light amounts of fluid, spray and/or aerosols are produced. Level 2 masks are suitable for restoratives, prophylaxis, sealants, limited oral surgery and endodontic work.
Level 3 masks (ASTM high barrier) are designed for procedures with moderate to heavy amounts of blood, fluid, spray and/or aerosol exposure. High barrier protection is needed for procedures such as implant placement, crown preparation, and periodontal or complex oral surgery. Protecting against high bacterial infiltration, Level 3 masks feature a 5-ply design with a fluid resistant outer layer.
At this point in the coronavirus pandemic, it’s clear that infected people can spread the virus before they start to show any symptoms.
Because of this, the Centers for Disease Control and Prevention and an increasing number of state health departments have recommended that most people wear face coverings or nonmedical masks while out in public. (Certain groups, such as children under age 2, are excluded from the advice.)
N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face. Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) also regulate N95 respirators.
It is important to recognize that the optimal way to prevent airborne transmission is to use a combination of interventions from across the hierarchy of controls, not just PPE alone.
Medical masks and other face coverings protect other people from the person wearing the mask. N95 protects the person wearing the mask from other people.
Both N95s and surgical masks are made from melt-blown fabric, which is difficult and expensive to make.
The material is a fine mesh of synthetic polymer fibers so thin that the wearer can block infectious particles and breathe simultaneously.
It’s made from a machine that melts down plastic material and blows it out into fabric sheets using hot air. The resulting material is called melt-blown fabric.
A mask is effective only if worn properly, fitting snugly from the top of the nose to below the chin with no gaps. Masks should be worn the entire time you are outside, and should not be moved up and down. While no mask is 100 percent effective, it can help keep both you and others safe when combined with social distancing and regular hand washing.
Many disposable respirators have anti-microbial surfaces, but over the years that they could start to be considered home to germs. It is recommended to change them out after 8-10 hours even if they’re not cluttered.
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.
N95 respirators are approved by NIOSH as to their respiratory protection efficiency and resistance and other NIOSH requirements. They are also separately cleared by FDA as medical devices. … Surgical N95 respirators and N95 industrial respirators share the same NIOSH requirements. The masks at cv-mask.com are industrial type.
The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death.
An N95 respirator is a respiratory protective face mask, designed to help reduce the user’s exposure to airborne particles including very small particles (0.3 microns) and large droplets. N95 respirator face mask literally has a filtration efficiency of at least 95% against non-oily particles.
The N95 is the most recognizable and effective mask. Its name means it can block at least 95 percent of tiny particles — 0.3 microns — that are the hardest to capture. An average human hair is about 70 to 100 microns wide.
These masks, which are designed for single use, are made with polyester and other synthetic fibers, including layers of tangled fibers that act as a filter to make it harder for particles to pass through.
N95 respirators are designed to provide a better seal around the face and built especially to filter smaller particles—the 95 in the name comes from how, in testing, the respirator blocks 95% of 0.3 micron-sized test particles. Neither masks nor respirators are intended to be used more than once.
Make sure there are no gaps between the edge of the mask and your skin. This one includes a nose piece that is molded to your face. Many health care and other workers do annual fit tests that check for air leakage and ensure that masks are sized and fit properly. (If you have facial hair, you won’t get a proper fit. They don’t fit well on children, either.)
One important addition to your respiratory protection plan should be reuse of N95 respirators during a shortage. The OSHA directive indicates that a respirator can be reused as long as it “maintains its structural and functional integrity and the filter material is not physically damaged or soiled.”
To clean and disinfect appropriate masks, gently wash the mask in warm soapy water, using dishwashing liquid. Rinse in clean water and plunge the entire mask body into a disinfection solution of 1/4 cup of non-scented liquid chlorine bleach per gallon of water.
Masks must be changed when they become wet with saliva or other bodily fluids, as they lose their protective properties. Medical masks are not tested against specific microorganisms and do not prevent specific diseases. Never reuse, wash or disinfect surgical masks. Never share surgical masks with others.
The KN95 mask is designed to filter out at least 95% of particles that are 0.3 microns or larger in size – the same measure used for the scarce N95 mask. Like the N95, it fits closely around the nose and mouth, creating a seal that decreases the risk of infection. And the Center for Disease Control has said it’s as effective as N95, which is certified under US testing standards. But this second type of mask, called the KN95, complies with slightly different norms and is made in factories that have not been certified by the U.S. government.
According to 3M, the world’s largest mask manufacturer, the KN95 is “equivalent” and “can be expected to function very similar” to the N95 mask. That opinion was echoed on February 29 by the CDC, which said the KN95 is one of the seven foreign-certified respirators “expected to provide protection to workers”…
The two rubber bands on an N95 mask go around the back of your head. On a KN95, the rubber bands go around your ears.
Features of KN95: 100% brand new and high quality
* KN95 level protection, filtering efficiency up to 95%, PM 2.5 pollution ash.
* The production of our masks strictly follows GB2626-2006 (China’s KN95 standard). The technical requirements and test methods of GB2626-2006 (China’s KN95 standard) are basically consistent with 42 CFR 84 (US standard) for NIOSH N95..
* Activated carbon layer inside can effectively absorb organic smell and odor.
* High-quality elastic ear-loop with no pressures on the ears, makes it comfortable to wear for a long time.
* Close fit to prevent polluted air from entering.
* Nose sponge cushion, soft and flexible nose cushion makes mask wearer feel more comfort.
* Adjustable soft nose clip, fit the bridge of the nose, prevents fogging of glasses block the haze from entering.
* Wide applications: can be used for electronic manufacturing, dust-free workshops, catering services, food processing, schools, motorcycles, beauty, environmental cleaning, public occasions and many other uses. All the filter efficiency indicators are above 95%.
Disposable Civilian and Medical Masks
Civilian and Medical masks come in a few varieties and are less effective than N95s: Some filter as much as 60 to 80 percent of small particles under lab conditions. When worn properly, they can help prevent the spread of the coronavirus by catching droplets when you cough or sneeze.
Civilian and Medical masks are often made out of layers of breathable, paper-like synthetic fabric that is cut into a rectangular shape and has pleats to help it expand and fit more snugly around your face. They are disposable and designed to be used just once.
While they can protect you from large droplets and splatter, their looser fit is partly what makes them less effective than N95s.
It has the blue color on the outside because it is waterproof and then you have white on the inside because it is absorbent. So, if one coughs, it absorbs it.
Medical masks are made to be fluid resistant, with the waterproof layer on the outside to “minimize the amount of fluid that could transfer from the outer layers through to the inner layers as the result of a splash or spray,” in accordance with the American Society of Testing and Materials standards.
The filtration efficiency and protective ability of a civilian/medical face mask is compromised when the mask becomes wet, torn or dislodged.
Respirators with a nanofiber filter are optimal for daily use against smog, bacteria and other airborne viruses. Masks made of nanosized fibers have up to a 99.9% efficiency in stopping viruses and are very comfortable to wear. The wearer can breathe as comfortably as wearing a conventional face mask, making it superb for any outdoor occasions.. The face masks are made up a thin non-woven fabric with a very low weight nanofiber coating that is ideal with its flexible structure that easily passes moisture. This process allows the masks to be washed regularly, and after 20 washings will still be able to filter about 94% of contaminants and retain its shape.
Nano-fiber filters are generally used in air filtration systems and are made through an electro-spinning process that creates an extremely thin, fibrous material, which is then inlaid in a filter. These nanofiber webs are so taut—and have such microscopic holes in them—that larger pieces of dust and contaminants aren’t able to penetrate them.
Additionally, it maintains its ability to filter out contaminants – like viruses – even after being washed. This means you will be able to thoroughly wash these masks before reusing them, a big improvement on having to repeatedly reuse and cleanse single-use masks. (Though these masks are more sustainable over time than the N95, they filter out roughly 4% fewer particles than standard masks do, which is still enough to filter out the virus pathogens.)
Even after undergoing 20 rounds of washing, the nanofiber design is able to successfully filter 94% of contaminants (namely bacteria with ethanol) and retained its original shape.
|CLASSIFICATION||MELT-BLOWN MASK||NANOFIBER MASK|
|Characteristics||Initial filtration efficiency sharply decreases as electrostatic force discharge with usage||The greater surface area of nanofibers increases the mechanical filtration efficiency, able to maintain high efficiency for over 20 washings.|
The FDA regulates medical masks and N95 respirators differently based on their intended use.
A medical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. These are often referred to as face masks, although not all face masks are regulated as medical masks. Note that the edges of the mask are not designed to form a seal around the nose and mouth.
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Face-piece Respirators (FFRs), often referred to as N95s.
People with chronic respiratory, cardiac, or other medical conditions that make breathing difficult should check with their health care provider before using an N95 respirator because the N95 respirator can make it more difficult for the wearer to breathe. Some models have exhalation valves that can make breathing out easier and help reduce heat build-up. Note that N95 respirators with exhalation valves should not be used when sterile conditions are needed.
All FDA-cleared N95 respirators are labeled as “single-use,” disposable devices. If your respirator is damaged or soiled, or if breathing becomes difficult, you should remove the respirator, discard it properly, and replace it with a new one. To safely discard your N95 respirator, place it in a plastic bag and put it in the trash. Wash your hands after handling the used respirator. Due to shortages, follow the cleaning and disinfecting instructions for KN95, N95 and NIOSH N95 masks. Disposable civilian and medical masks are not recommended for cleaning due to degradation of material make-up of these masks.
N95 respirators are not designed for children or people with facial hair. Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection. In this case, using a disposable or medical mask is recommended.
Most N95 respirators are manufactured for use in construction and other industrial-type jobs that expose workers to dust and small particles. They are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC)
However, some N95 respirators are intended for use in a health care setting. Specifically, single-use, disposable respiratory protective devices used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.
The similarities among medical masks and N95s are:
Actually, both the N95, KN95, FFP2 respirators have almost the same filtration efficiency, it means that KN95, FFP2 are as effective as the N95 respirator mask. The main difference between these respirators is that they are tested by different nations.
The N95 mask has a full name of NIOSH-certified N95 respirator, which means these respirators are tested of 95% filtration and certified by the U.S. National Institute of Occupational Safety and Health (NIOSH). The KN95 respirator is a particulate-filtering mask tested using the China criteria. The FFP2 is a filtering face-piece score of 94% filter capacity approved by Europe..
To simply put, we could put these respirators into an equation as below:
N100 (99.97%) = FFP3 (99.95%) > N95 (95%) = KN95 (95%) = FFP2 (94%).
Of all the body parts that PPE protects, the face and eyes are among the most vulnerable. Many safety incidents involve a workers’ face or eyes getting struck by an object, injured by flying particles, burned by acids or chemicals, or exposed to light radiation. In many of these cases, a worker suffers permanent damage to their vision or even goes blind.
Workers and their employers frequently underestimate the risk of eye and face injuries. Employees may neglect to wear eye and face protection or remove their PPE before it is safe to do so. Common complaints are that the PPE doesn’t fit comfortably, is too hot, or makes the wearer look unattractive. For goggles and safety glasses in particular, a major problem is the equipment fogging up, causing the wearer to periodically remove it and clean off moisture. CV-MASK.COM sell only non-fog goggles.
PROTECTIVE FACE SHIELD
A face shield is classified as personal protective equipment (PPE) that provides barrier protection to the facial area and related mucous membranes (eyes, nose, lips).
A face shield is a device used to protect wearer’s entire face (or part of it) from hazards such as flying objects and road debris, chemical splashes (in industry), or potentially infectious materials (in medical and laboratory environments).
Purpose. Eye and face protection shall be required where there is a reasonable probability that injury could be prevented by such protection. PPE shall be selected in accordance with IOSH 1910.133, Eye and Face Protection.
PROTECTIVE FACE SHIELD ATTRIBUTES:
NON-FOG EYE GOGGLES
There’s a long-standing myth that wearing safety glasses can harm your vision. Workers are worried if it’s healthy for their eyes to be looking through a “plastic” (aka polycarbonate) lens all day while on the job. … The short answer is no – wearing safety eyewear cannot damage your vision.
Safety goggles are important for a number of reasons. To begin with, they allow the wearer to handle potentially harmful chemicals without fear of damaging their eyes. This can also be true to biological matter. … Safety goggles can also help to protect an individual from harm to the eye from physical trauma.
NON-FOG GOGGLES ATTRIBUTES:
The most popular lens material for safety eyewear is polycarbonate. This material has less than half the weight of glass making the eyewear more comfortable to wear. Polycarbonate lenses are also more impact-resistant than glass lenses and do not shatter.
Journal of Occupational and Environmental Hygiene
Taylor & Francis
J Occup Environ Hyg. 2016; 13(4): 235–242.
Published online 2016 Feb 22. doi: 10.1080/15459624.2015.1095302
Face shields for infection control: A review
Face shields are personal protective equipment devices that are used by many workers (e.g., medical, dental, veterinary) for protection of the facial area and associated mucous membranes (eyes, nose, mouth) from splashes, sprays, and spatter of body fluids. Face shields are generally not used alone, but in conjunction with other protective equipment and are therefore classified as adjunctive personal protective equipment. Although there are millions of potential users of face shields, guidelines for their use vary between governmental agencies and professional societies and little research is available regarding their efficacy.
Healthcare workers’ faces have been reported to be the body part most commonly contaminated by splashes, sprays and spatter of body fluids. A face shield is classified as personal protective equipment (PPE) that provides barrier protection to the facial area and related mucous membranes (eyes, nose, lips). A face shield offers a number of potential advantages, as well as some disadvantages, compared with other forms of face/eye protection used in healthcare and related fields
The introduction of the Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens Standard 1910.1–030, as well as recent outbreaks of serious airborne infectious diseases (e.g., Severe Acute Respiratory Syndrome [SARS], Avian Influenza, etc.) and severe infectious agents associated with the potential for body fluid exposures (e.g., Ebola virus), have resulted in increased attention to face/eye protection.
|· -more comfortable
· -protect a larger portion of the face
· -less retained dermal facial heat
· -less fogging than goggles
· -less claustrophobic
· -no impact on breathing resistance
· -no fit testing required
· -can be disinfected easily
· -wearers do not need to be clean shaven
· -easy to don and doff
· -relatively inexpensive
· -no impact on vocalization
· -can be worn concurrent to other face/eye PPE
· -do not impede facial nonverbal communication
· -reduced patient anxiety
· -protects against self-inoculation over a wider facial area
· -may extend the useful life of a protective facemask when used concurrently
· -optically imperfect
· -some models may not fit properly over some respirators (e.g., duckbill filtering facepiece respirators)
· -bulkier than goggles and safety glasses
· -peripheral fit poorer than protective facemasks
Disposable one-piece face/neck length face shield visor assembly with foam forehead cushion and elastic strap.
Face shields provide a barrier to acutely-expelled aerosols of body fluids and are commonly used as an alternative to goggles as they confer protection to a larger area of the face. However, as highlighted in a recent Institute of Medicine report, little is known about the effectiveness of face shields in preventing the transmission of viral respiratory diseases. Utilizing a cough aerosol simulator loaded with influenza virus (aerosol volume mean diameter of 8.5 µm) and a breathing simulator, Lindsley et al. reported 96% and 92% reductions in the risk of inhalational exposure immediately after a cough for a face shield at distances of 18 in (46 cm) and 72 in (183 cm), respectively. Decreasing the aerosol size to 3.4 µm resulted in the face shield blocking 68% of the inhalational exposure at 18 in (46 cm) immediately after the cough and 23% over 1–30 min post-cough (during which time the larger aerosol particles had settled out and droplet nuclei had formed and remained airborne so that flow occurred more easily around the edges of the face shield). Shoham et al.
They found that a face shield with head/neck length, three separate contact points at the forehead, and side curve reaching to the point of the ear (Bettershield™, Southmedic, Barrie, Ontario, CA), or the combination of this face shield and an N95 filtering facepiece respirator (N95 FFR), protected the eyes, nares and mouth from contamination.
There is great variance in official (governmental) and professional society (medical, dental, etc.) guidelines for the appropriate use of face shields in the context of protection from biological hazards. Healthcare Infection Control Practices Advisory Committee/CDC Standard Precautions guidelines for prevention of transmission of infectious agents in healthcare venues includes the use of face shields (with a medical/surgical face mask) when sprays, splashes, or splatter are anticipated. The World Health Organization’s health care facility recommendations for standard precautions include a face shield as an alternative to the use of a medical/surgical or procedural mask with eye protection (eye visor or goggles). Similarly, the Ohio State Dental Board guidelines for infection control states that dental healthcare workers need not wear medical/surgical masks when wearing an appropriate face shield that provides protection at both the top and the sides.32] The Organization for Safety, Asepsis, and Protection, an advocacy group for dental practitioners, advises that use of a face shield alone for protection from contamination by body fluids is likely insufficient, and it is prudent to assume that in those situations where a face shield is used to protect against splash or splatter, a medical/surgical mask would also be indicated.
The use of a minimum of an N95 FFR, concurrent with a face shield, has been advocated for protection from serious airborne respiratory infectious diseases (e.g., novel influenza A viruses, SARS) and during procedures on infected persons that result in aerosolization of body fluids (airway suctioning, intubation, etc.).
Face shields are meant to be used as barrier protection for the facial area and associated mucous membranes from airborne body fluids (blood, saliva, bronchial secretions, vomit, urine, etc.) expelled as a result of various physiological processes (vomiting, coughing, sneezing, etc.) and medical, dental, and veterinary procedures (suctioning the airway, placing nasogastric tubes, obstetrical procedures, surgery, dental procedures, etc.).
Appropriately fitted, indirectly vented goggles offer the most reliable practical eye protection from splashes, but face shields are considered an alternative to goggles for prevention of eye contamination with infectious agents.
Use of a face shield alone for eye, face, and mucous membrane protection from contamination by body fluids is likely insufficient and it has been recommended that in those situations where a face shield is used to protect against splash or splatter, a medical/surgical mask would also be indicated.
A face shield can provide additional protection to other facial areas that safety glasses or goggles cannot. Face shields are considered to be a secondary protector and must always be worn over protective safety glasses or goggles. To provide better face and eye protection from splashes and sprays, a face shield should have crown and chin protection and wrap around the face to the point of the ear, which reduces the likelihood that a splash could go around the edge of the shield and reach the eyes. Disposable face shields for medical personnel made of light weight films that are attached to a surgical mask or fit loosely around the face should not be relied upon as optimal protection. Cartridge respirators not only have the ability to filter the air before you breathe, but can also be used as eye protection. They will protect the eyes and all parts of the face.
The face shields are made from a clear flexible acetate or polypropylene (PP) material at 5 to 10 mils thick.
CV-MASK.COM’s non-fog eye goggles fit adequately over prescription glasses with minimal gaps. However, to be efficacious, goggles must fit snugly, particularly from the corners of the eye across the brow. While highly effective as eye protection, goggles do not provide splash or spray protection to other parts of the face.
Protective goggles form a protective seal around both eyes where the material is tight or flush to the face. Appropriately fitted, indirectly-vented goggles* with a manufacturer’s anti-fog coating provide the most reliable practical eye protection from splashes, sprays, and respiratory droplets. Newer styles of goggles may provide better indirect airflow properties to reduce fogging, as well as better peripheral vision and more size options for fitting goggles to different workers.
Think Safety Glasses AND Face Shield
However, you should always wear safety glasses under your face shield because the bottom and sides of face shields typically have gaps. Liquid or debris passing through these gaps can contact your eyes, potentially causing an injury.
All protectors must:
These page is from CDC description of gowns: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g1
Gowns are examples of personal protective equipment used in health care settings. They are used to protect the wearer from the spread of infection or illness if the wearer comes in contact with potentially infectious liquid and solid material. They may also be used to help prevent the gown wearer from transferring microorganisms that could harm vulnerable patients, such as those with weakened immune systems. Gowns are one part of an overall infection-control strategy.
A few of the many terms that have been used to refer to gowns intended for use in health care settings, include surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.
In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate that the gown provides the newly defined levels of protection:
Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
Regardless of how the product is named (that is, isolation gown, procedure gown, or cover gown), when choosing gowns, look for product labeling that describes an intended use with the desired level of protection based on the above risk levels. Product names are not standardized.
CV-MASK.COM ONLY SELLS NON-SURGICAL ISOLATION CLASS I GOWNS.
OUR GOWNS ARE NOT PRE-STERILIZED AND MEET ASTM STANDARDS FOR MEDICAL USE. OUR GOWNS ARE EXPORT CONTROLLED TO MEET THE STANDARDS OF GOWNS ASSIGNED BY THE FDA.
Non-Surgical (ISOLATION) Gowns
Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.
Like surgical isolation gowns, non-surgical gowns should also cover as much of the body as is appropriate to the task. As referenced in below Figure, all areas of the non-surgical gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown.
Figure – Critical Zones for Surgical Isolation Gowns and Non-Surgical Gowns
The entire gown (areas A, B, and C), including seams but excluding cuff, hems, and bindings, is required to have a barrier performance of at least Level 1.
Surgical isolation gowns are used when there is a medium to high risk of contamination and need for larger critical zones than traditional surgical gowns.
Standards for Gowns
Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown.
The performance of gowns is tested using consensus standards:
American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
Below is a summary of ASTM F2407 standard recognized by the FDA.
Tensile Strength: ASTM D5034, ASTM D1682
Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
Seam Strength: ASTM D751 (stretch woven or knit)
Lint Generation (ISO 9073 Part 10)
Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75
American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Due to the high degree of hygiene required by the medical field, the standard version of these disposable surgical gowns can be sterilized in an autoclave at 134°C.
CLICK THIS LINK TO REVIEW STUDIES OF NON-STERILE ISOLATION GOWNS:
CLICK THIS LINK TO REVIEW WHAT ARE AND THE DIFFERENCES BETWEEN SMS AND PP MATERIAL USED IN MOST MEDICAL GOWNS:
CLICK THIS LINK TO REVIEW A STUDY OF NON-WOVEN SURGICAL GOWNS:
Our hand sanitizers are FDA Registered & Audited – GMCP Certified – INTERTEK Certified – BSCI & C-TPAT Audited.
Our hand sanitizers have been audited by the FDA, reviewed and tested by FDA laboratories for safe and authentic ingredients conforming to FDA labeling requirements.
Our hand sanitizers are third party (independently) verified by SGS for ETHANOL (Ethyl Alcohol) content, ingredient identification, and label conformance.
Third-party testing assures safety and reliability for you.
It is the same as sold to brands Americans trust including DISNEY, WALMART, FAMILY DOLLAR, WATSON’S & other internationally known brands.
The ingredients of our hand sanitizer are ethyl alcohol (75%), water, glycerin, carbomer, aloe vera gel, propylene glycol, triethanolamine, fragrance, vitamin E.
Alcohol has been used as an antiseptic at least as early as 1363 with evidence to support its use becoming available in the late 1800s. Alcohol-based hand sanitizer has been commonly used in the west since at least the 1980s. The alcohol-based version is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system.
Benefits of waterless hand sanitizer:
Health officials say that soap and water is the best way to keep your hands virus-free. When you’re not near a sink, the experts say, hand sanitizers are the next best thing. To get the maximum benefit from hand sanitizers, the Centers for Disease Control and Prevention (CDC) recommends that people use a product that contains at least 60% alcohol, cover all surfaces of their hands with the product, and rub them together until dry.
Our hand sanitizer is composed of 75% ethyl alcohol. Care should be taken as they are flammable. Alcohol-based hand sanitizer works against a wide variety of microorganisms. Compounds such as glycerol (propylene glycol) are added to prevent drying of the skin. Non-alcohol based versions typically contain benzalkonium chloride or triclosan; but are less effective than alcohol-based ones.
Nitrile is short for acrylonitrile-butadiene rubber. This material is created from monomers – acrylonitrile and butadiene – which are molecules that are bonded together. Nitrile gloves come in a wide variety of colors, which can help to differentiate sizing and prevent cross contamination
Nitrile is waterproof, greaseproof, oil proof and most importantly, chemical resistant to a range of common chemicals and substances. Nitrile gloves are also commonly used in the medical industry due to their high puncture resistance, and dexterous strength.
Since Nitrile gloves are made out of a synthetic rubber, they are an ideal alternative when latex allergies are of concern. Nitrile gloves are the superior glove when it comes to puncture resistance. Nitrile gloves are often referred to as “medical grade.”
Nitrile gloves are therefore more puncture-resistant than natural rubber gloves, especially if the latter are degraded by exposure to chemicals or ozone. Nitrile rubber is less likely to cause an allergic reaction than natural rubber.
In general, nitrile is often considered premium to latex, which in turn is often considered premium to vinyl. The fact is that materials are not equal in performance in all applications. CV-MASK.COM does not sale latex gloves.
Nitrile gloves are preferred over latex because of their chemical resistance, their tendency to visibly rip when punctured, and to prevent possible latex allergies.
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Vinyl gloves are a popular choice for the food industry and situations where high levels of durability and protection are less of a priority. While they may be less durable, they are the less expensive option.
So, when it comes time to decide which type of protective glove is the right choice for you, the most important thing to consider is….how much protection do you need.
Am J Infect Control. 1999 Oct;27(5):405-10.
In-use barrier integrity of gloves: latex and nitrile superior to vinyl.
This study indicates that the latex and nitrile gloves evaluated were comparable in terms of barrier performance characteristics both unused and during manipulations mimicking patient care procedures. Whereas stretch vinyl exhibited lower failure rates than standard vinyl, the higher in-use leakage rates associated with all vinyl gloves tested indicate decreased durability and, potentially, compromised barrier protection when this synthetic is used. Careful consideration to the degree of barrier effectiveness should be given before glove selection when the potential exposure to blood-borne pathogens or biohazard risks is a concern.
Vinyl gloves, also called PVC gloves, contain a heavy chlorine content. PVC is a widely produced synthetic plastic polymer. … And, the European Union in 2008 banned the use in food safety products of at least one material used in making vinyl gloves out of concern the chemical could leach into food and be ingested.
Vinyl gloves, which are made from PVC (polyvinyl chloride), are usually the cheapest latex-free gloves. However, many prefer to use higher-end gloves such as nitrile gloves. … In general, latex gloves offer the best protection against bacteria and viruses, while synthetic gloves provide better chemical protection.
Gloves made from vinyl are manufactured in a way to enable stretch and versatility whilst they are also able to hold up against punctures, stretch and general wear and tear. They can be used for healthcare tasks, keeping hands safe from contamination.
Four phthalates were found in some vinyl gloves, alone or in combination with one another: DEHP (the most toxic), DINP (the unsafe alternative), DIDP (has growing concern) and DPHP (closely related to DIDP, increasingly used).
Phthalates. Up to 50% of disposable vinyl gloves are made up of plasticizers, which make the PVC flexible and soft enough to wear. Often plasticizers contain phthalates and BPA as they are inexpensive.
Up to 50% of disposable vinyl gloves are made up of plasticizers, which make the PVC flexible and soft enough to wear. Often plasticizers contain phthalates and BPA as they are inexpensive. Phthalate plasticizers can be absorbed through worker’s skin and quickly transfer to, and contaminate food products.
Vinyl is a synthetic, non-bio-degradable, protein-free material made from polyvinyl chloride (PVC) and plasticizers. Since vinyl gloves are synthetic and non-biodegradable, they have a longer shelf life than latex gloves, which often start to break down over time.
Nitrile gloves protect against most chemicals and infectious agents. Neoprene gloves protect against most solvents, oils, and mild corrosive materials. Avoid latex gloves as many people are allergic or develop allergies to this material.
Nitrile rubber gloves offer superior puncture-resistant to latex gloves. Nitrile rubber gloves offer a greater chemical resistance over Latex and vinyl to chemicals, oils, and acids, and have superior strength. This type of glove creates a better barrier for protection.
It is important to wear gloves when working with hazardous chemicals and other materials because they protect our hands from infection and contamination. Protective gloves should be selected on the basis of the hazards involved. Nitrile gloves protect against most chemicals and infectious agents.
Like other glove types, nitrile gloves are sensitive to alcohol degradation. They have been found to be sensitive to ozone degradation and can be somewhat brittle and stiffer than latex. Nitrile gloves may contain bis(2-Ethylhexyl)phthalate, or DEHP, recognized as carcinogenic.
An easy way to do this is first put the nitrile or latex glove on your dominant hand, while touching it as little as possible. Then, put the other glove on your non dominant hand, using your gloved dominant hand to pull it on. Once both gloves are on your hands you can adjust your fingers and the fit of the glove.
Most disposable nitrile gloves come in different thicknesses, or gauges, ranging from four to eight mil thick. The vast majority of heavy duty industrial grade nitrile gloves will be 6 – 8 mils thick.
Nitrile is a synthetic rubber copolymer of acrylonitrile and butadiene. These two materials (monomers) are placed in a stainless steel vat, and using hot or cold polymerization, a chemical reaction occurs, and voila! Nitrile is born.
While an exact shelf life time period is dependent on what specific material the gloves are made of and storage facilities, a general rule of thumb is three years for disposable natural latex gloves and up to five years for disposable nitrile gloves.
Yes, they can be washed as long as no material degradation is present. We recommend hand washing your Nitrile gloves or Vinyl gloves in a sink using mild laundry detergent or dishwashing soap. DO NOT use bleach or solvents as these oxidizing agents can cause discoloration. We recommend air-drying your gloves to prevent any material shrinkage and maintain proper sizing.
Nitrile gloves are designed not to be reused, actually. But, if you’re careful about how you pull them off, it’s possible to get a couple of uses out of them. The tricky part is getting them from inside-out (which they’ll be after you pull them off) back to right-side-out again, especially with the very thin ones.
Traditionally Nitrile gloves come in a blue hue in order to differentiate them as a non-latex glove for people with latex allergies. The reason for such color variation in Nitrile gloves is mostly due to industry preference. They can come in the colors of the rainbow, but the most typical colors are blue, black and white. No matter the color they all work the same.
Yes, they can. Some users of nitrile gloves have reported allergic reactions triggered by other antigens in the synthetic material but not by latex proteins, which cause latex allergies. … Three main kinds of accelerators cause contact dermatitis: carbamates, mercaptobenzothiazole (MBT), and thiurams.
Glove-related allergies are a primary concern for many glove users. The belief that glove-related allergies are caused only by natural latex is a common one. Latex allergies are the most serious glove allergies because they can be systemic and cause anaphylactic shock. Latex allergies are also the most common type of glove allergies.
Some users confuse chemical allergies with latex allergies. There are often components in both nitrile and vinyl gloves that can elicit a chemical allergy. For example, nitrile gloves, like natural latex gloves, often use carbamates or thiazoles, which can cause a skin allergy. Certain vinyl gloves use activation agents that can also cause skin allergies. In all cases, the less a glove is washed, the more chemical residue is available for potential contact to the user. Users should consult their physician if they suspect an allergy to gloves.
Latex allergies are the most serious glove allergies because they can be systemic and cause anaphylactic shock. … For example, nitrile gloves, like natural latex gloves, often use carbamates or thiazoles, which can cause a skin allergy. Certain vinyl gloves use activation agents that can also cause skin allergies. CV-MASK.COM does not offer latex gloves for sale.
Even more rarely, there are sometimes trace amounts of latex found in nitrile gloves, which causes a latex allergy that is falsely attributed to the nitrile glove. The typical symptoms associated with an allergic reaction to nitrile gloves are listed below: Redness of hands. Rhinitis: stuffy or runny nose.
Toxicity of medical glove materials: a pilot study. Lönnroth EC(1). Author information: … One synthetic rubber glove (nitrile rubber) and 2 synthetic polymeric gloves (polyvinyl chloride) were non-toxic in all 3 tests.
Choosing the right glove type or source is not as simple as reviewing a specification or buying at the lowest price. A number of critical factors should be considered. Understanding the truths about glove performance is important in selecting the right glove for each application.
When deciding between nitrile and vinyl gloves…it can be a little confusing trying to determine which type of glove is the ideal choice. Let’s take a closer look at the attributes and benefits of each type of glove.
Nitrile gloves are the most non-allergenic disposable glove available: made out of synthetic rubber, and are an ideal alternative when latex allergies are of concern. Nitrile gloves are the superior glove when it comes to puncture resistance. Nitrile gloves are often referred to as “medical grade.” Before gloves can be marketed to hospitals and medical institutions, they must undergo a series of tests conducted by the Food and Drug Administration (FDA) to ensure their durability.
Nitrile gloves are much more resistant than Vinyl gloves but more expensive. The biggest differences are in elasticity and mechanical resistance: for this reason, vinyl gloves are less sensitive and break more easily, even with a simple finger press.
Glove suppliers frequently claim glove composition of “100%” of the respective materials. Without additives, it is practically impossible to produce a usable glove of any of these materials. Adding curatives, cross-link agents, and accelerators to nitrile and natural latex is essential to making a strong, durable glove. Vinyl requires plasticizers and activation agents. Surfactants, which help with film formulation, are another additive found in most gloves. Formulations typically require 4-10 percent of additives to make a good glove