What Are the Advantages of Disposable Face Mask？

Companies interested in developing NIOSH-approved respirators should be aware of FDA's intention to issue in FY a draft guidance for public comment, "Enforcement Discretion Policy for Premarket and Other Requirements for NIOSH-Approved Air Purifying Respirators", as noted on CDRH's A-list published on October 10, (CDRH Proposed Guidances for Fiscal Year (FY) | FDA), which may impact development plans and requests for FDA feedback.

View Details

N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from particles or from liquid contaminating the face. The Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) also regulates N95 respirators. The Department of Labor's Occupational Safety and Health Administration (OSHA) regulates entities for compliance with worker safety rules and OSHA standards, including, for example, the proper use of respirators in different work environments.

It is important to recognize that the optimal way to prevent transmission of microorganisms, such as viruses, is to use a combination of interventions from across the hierarchy of controls, not just PPE alone.

COVID-19 Resources on Respirators and Masks

Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19: Answers to frequently asked questions

On this page:

Face Masks

A face mask is a product that covers the wearer's nose and mouth. Face masks are for use as source control by the general public and health care personnel (HCP) in accordance with CDC recommendations, and are not personal protective equipment. Face masks may or may not meet any fluid barrier or filtration efficiency levels; therefore, they are not a substitute for N95 respirators or other Filtering Facepiece Respirators (FFRs), which provide respiratory protection to the wearer, or for surgical masks, which provide fluid barrier protection to the wearer.

Barrier Face Coverings

A barrier face covering, as described in ASTM F-21, is a product worn on the face specifically covering at least the wearer's nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate material. Barrier face coverings are not a substitute for N95 respirators and other Filtering Facepiece Respirators (FFRs), which provide respiratory protection to the wearer, or for surgical masks, which provide fluid barrier and particulate material protection to the wearer.

Barrier face coverings may be made from a variety of materials that are not flammable. By definition, a barrier face covering should meet the particulate filtration efficiency, airflow resistance, and leakage assessment recommendations as described in ASTM F-21. 

Surgical Masks

A surgical 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. Surgical masks are regulated under 21 CFR 878.. Surgical masks are not to be shared and may be labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without a face shield. These are sometimes referred to as face masks, as described above, although not all face masks are regulated as surgical masks.

Surgical masks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the face mask and how well the surgical mask protects you.

If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others.

While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, it does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.

Surgical masks are not intended to be used more than once. If your surgical mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove it, discard it safely, and replace it with a new one. To safely discard your surgical mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask.

N95 Respirators

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 Facepiece Respirators (FFRs), often referred to as N95s.

Comparing Surgical Masks and Surgical N95 Respirators

The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.

A surgical 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 surgical 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 Facepiece Respirators (FFRs), often referred to as N95s.

General N95 Respirator Precautions

• 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.
• 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.

N95 Respirators in Industrial and Health Care Settings

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).

Additional reading:
Guide to Dental Extraction Forceps

APC Med are exported all over the world and different industries with quality first. Our belief is to provide our customers with more and better high value-added products. Let's create a better future together.

However, some N95 respirators are intended for use in a healthcare setting. Specifically, single-use, disposable respiratory protective devices used and worn by healthcare personnel during procedures to protect both the patient and healthcare 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., and CDC NIOSH under 42 CFR Part 84.

N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:

• The respirator is intended to prevent specific diseases or infections, or
• The respirator is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or
• The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).

The FDA has a Memorandum of Understanding (MOU) with CDC NIOSH which outlines the framework for coordination and collaboration between the FDA and NIOSH for regulation of this subset of N95 respirators.

For additional differences between surgical masks and N95 respirators, please see CDC's infographic.

has been an iconic year in many ways ' one that most of us are anxious to leave behind. But we've also learned a lot this year, especially about health and safety, especially how to stay safe in our communities. Keeping ourselves, our families, and our communities safe is a responsibility we all share. So when it comes to personal protective equipment ' or PPE ' our goal at Flents is to make safety simple. We call this 'Do It YourSelf Care' and we're here to demystify any complexities of care.

One question that comes up over and again is whether reusable masks or disposable masks are better for protection against small airborne particles. Google 'benefits of disposable face masks' and you're bound to get differing views on whether the throw-away paper masks are ideal or not. Since we're here to demystify the world of 'Do It YourSelf Care,' we'll break it down nice and simple. 

To understand the benefits of disposable masks, we need to first talk about the different types of common face masks available on the market today. Keep in mind effectiveness is relative to wearing the mask properly to reduce potential contact by the wearer.

Types of Face Masks 

N95 Face Masks (disposable)

N95 masks have been deemed the Cadillac of face masks, and are, according to OSHA, effective in protecting against COVID-19. These masks block 95% of small airborne particles. These masks have been widely reserved for essential workers, however are becoming more available. Flents offers two versions under the PROTECHS® label: a foldable N95 Respirator Mask, and a round N95 Respirator Mask. Both comply with OSHA regulations and are NIOSH® approved.

Surgical Face Masks (disposable)

Traditionally worn in hospitals for procedures and in surgical suites, surgical masks are generally thin and loose fitting. They do help protect from spreading potentially infectious droplets between individuals. Flents offers both a standard surgical earloop mask and a medical-grade earloop mask, both under the PROTECHS label.

Cloth Face Masks (reusable)

The rise in cloth masks happened in response to diminished N95 and surgical mask availability at the beginning of . Although an N95 has been proven to be the best defense against COVID-19, cloth masks are surprisingly effective if worn correctly. The most effective cloth masks are made from at least two layers of fabric with a thread count of 180 or more and can be adjusted for a close fit around the face. In an effort to preserve supply for essential workers, many organizations including John Hopkins were offering patterns for home-made cloth masks. Fitted with a disposable mask liner, these masks can provide excellent protection up to 99% Bacterial Filter Efficiency.

Other Types of Face Masks (reusable)

In addition to paper and cloth face masks, people are also using face shields, bandanas, and neck gaiters to protect themselves.

Since the purpose of the face shield is to provide more coverage to the wearer's face ' especially their eyes ' face shields are used commonly in conjunction with a face mask. Face shields are common in schools because of the sustained close contact, but according to the CDC, they are not effective as a standalone preventative measure or as a replacement for a face mask.

Bandanas and neck gaiters, are better than nothing, but neither provide effective coverage. Being open at the bottom, a bandana does not filter all air. The popular neck gaiter is often too thin to provide adequate protection.

So, what are the benefits of disposable masks?

• N95 disposable face masks are most effective. As mentioned above, according to OSHA, an N95 mask is effective in protecting wearers from the virus that causes COVID-19. It's hard to argue with that kind of endorsement.
• Disposable face masks are disposable. This is obvious ' but why is it important? Face masks are designed to protect against particles and droplets. If you come into contact with contaminated particles, throwing away your mask after use reduces the risk of the virus transferring to other surfaces and potentially infecting the wearer.
• Disposable face masks are more likely to have gone through the NIOSH approval process. NIOSH approval means that your mask has gone through rigorous testing and has met or exceeded standards for particle blockage, filtration and safety.
• Disposable face masks don't need to be washed. Many people who use reusable masks don't remember to (or realize they need to) keep their mask clean. Ideally, cloth masks should be washed daily in hot, soapy water, and dried completely. When was the last time you washed your reusable face mask?
• Disposable face masks are easy to keep on hand. We recommend keeping some disposable face masks on hand in the car, your purse, at your desk and anywhere else you may come in close contact with others. If you forget your reusable mask, a disposable mask is an easy back-up. Just remember to store extra masks in a plastic bag or other enclosed space so they don't get contaminated before use.

Deciding what type of mask is right for you is a personal decision. Disposable face masks certainly have different advantages than reusable face masks, but both can be effective when used correctly and in conjunction with social distancing. Whatever you decide is right for you and your family, Flents is here to help you 'Do It YourSelf Care.'

  

REFERENCES:

• Mayo Clinic: COVID-19: How much protection do face masks offer?
  https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-mask/art-

• Hartford HealthCare: Cloth Mask vs. Surgical Mask: The Surprising COVID-19 Winner
  https://healthnewshub.org/cloth-mask-vs-surgical-mask-vs-n95-how-effective-is-each/

• John's Hopkins Medicine: Coronavirus Face Masks & Protection FAQs
  https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-face-masks-what-you-need-to-know

• NPR: A User's Guide To Masks: What's Best At Protecting Others (And Yourself)
  https://www.npr.org/sections/goatsandsoda//07/01//a-users-guide-to-masks-what-s-best-at-protecting-others-and-yourself

• FDA: N95 Respirators, Surgical Masks, and Face Masks
  https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks#s2