FAQs

 

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.

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:

  • They are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency), flammability and biocompatibility.
  • They should not be shared or reused.

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%).

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

PMCID: PMC5015006

NIHMSID: NIHMS814057

PMID: 26558413

Face shields for infection control: A review

Raymond J. Roberge

 

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.[1] 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,[7] 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.

Advantages
· -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

Disadvantages

· -glare

· -fogging

· -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.[12] However, as highlighted in a recent Institute of Medicine report,[15] 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.[16] 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).[16] Shoham et al.[17]

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.[30] 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).[31] 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.

  1. While wearing gloves, carefully wipe the inside, followed by the outside of the face shield or goggles using a clean cloth saturated with neutral detergent solution or cleaner wipe.
  2. Carefully wipe the outside of the face shield or goggles using a wipe or clean cloth saturated with EPA-registered hospital disinfectant solution.
  3. Wipe the outside of face shield or goggles with clean water or alcohol to remove residue.
  4. Fully dry (air dry or use clean absorbent towels).
  5. Remove gloves and perform hand hygiene.

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:

  • Provide adequate protection against the particular hazards for which they are designed.
  • Be of safe design and construction for the work to be performed.
  • Be reasonably comfortable when worn under the designated conditions.
  • Fit snugly and not unduly interfere with the movements of the wearer.
  • Be durable.
  • Be capable of being disinfected.
  • Be easily cleanable.
  • Be distinctly marked to facilitate identification only of the manufacturer.

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:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4791533/

CLICK THIS LINK TO REVIEW WHAT ARE AND THE DIFFERENCES BETWEEN SMS AND PP MATERIAL USED IN MOST MEDICAL GOWNS:

http://www.heilymed.com/en/aboutus/industry_news/20170921/123.html

CLICK THIS LINK TO REVIEW A STUDY OF NON-WOVEN SURGICAL GOWNS:

https://www.researchgate.net/publication/258152943_Studies_on_the_properties_of_nonwoven_surgical_gowns

Am J Infect Control. 1999 Oct;27(5):405-10.

In-use barrier integrity of gloves: latex and nitrile superior to vinyl.

Rego A1Roley L.

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