Since the onset of the COVID-19 pandemic, many people have become interested (and rightly so) in the quality of PPE, or Personal Protective Equipment. PPE can include things like face shields, gloves, and face masks, like the ASTM Level 3 mask. Now that face masks are a requirement in many businesses and public areas, Americans want to be sure that their masks are actually keeping them safe. 


This brings up a number of important questions. Who regulates the manufacture of safety masks? Which safety masks offer the best protection? What role do the FDA and ASTM have in mask safety? And finally, what are the FDA standards for the ASTM Level 3 mask? We will answer all of these questions and more, but first, let’s look at the regulatory agencies that manage PPE.

Who Regulates the Manufacture of Safety Masks?


This is a relatively complex question, as there are a number of agencies and regulatory forces that contribute to the manufacture of safety masks and other forms of PPE. That said, the Food & Drug Administration (FDA) is the final voice when it comes to legal regulations of safety masks. Before the FDA finalizes these regulations, it works in tandem with the Centers for Disease Control & Prevention (CDC), as well as the American Society for Testing and Materials (ASTM). 


Generally speaking, the CDC conducts research to find the best solutions for public safety. ASTM provides templates so that PPE manufacturers know how to produce the safest and most effective protective equipment. Finally, the FDA uses all of the available data and research (in conjunction with the work done by the CDC and ASTM) to create regulations that all U.S.-based PPE manufacturers must follow. 

How Are Face Masks Evaluated?


The safety and efficacy of face masks are evaluated using six primary factors: 


  • Filtration
  • Exposure
  • Breathability
  • Fluid Penetration Resistance
  • Vapor Permeability
  • Water Repellency

However, the two most important factors for stemming the spread of COVID-19 are filtration and exposure. Let’s take a closer look at each to see how they can affect your health and safety:

Filtration


Part of a face mask’s job is to allow you to breathe without bringing in harmful particles. Thus, particles of a certain size must be filtered out. Typically, the type of filtration and the efficacy of the filter are the two most important determiners. The efficacy of a mask’s filtration system is measured using Particle Filtration Efficiency (PFE). According to Nelson Labs, PFE “involves the generation of a particle aerosol using NIST traceable polystyrene microspheres with a Particle Measurement Systems (PMS) Model PG-100 particle generator. The particles are counted with a PMS Model LASAIR II-110 or 310 laser particle counter.”


In other words, researchers send particles of varying sizes through a mask using a particle generator. They count the initial number of particles and then divide it by the number of particles that appear on the other side of the mask. This percentage provides a rough estimate of how effective a given mask design is against airborne particles. 

Exposure


While filtration is concerned with how many particles can get through a mask, exposure refers to the number of particles that can get around a mask. For example, when you wear a mask, you breathe in and out, sending particles through your mask. However, some of these particles escape through the sides, top, or bottom of the mask. The same applies to foreign particles. They can work their way into your mask through open areas. Thus, exposure is like a measure of the “tightness” of your mask.


Fortunately, Particle Filtration Efficiency (PFE) can also test a mask’s exposure. Using visual models, researchers can see how many particles bounce off of a mask, how many get caught in the filter, and how many work their way around the mask. The more particles there are working their way around, the lower a mask’s exposure rating. 

Which Face Masks Do the FDA, CDC, and ASTM Recommend?


There are a wide variety of face coverings, face shields, and safety masks available to American consumers. Needless to say, not all masks that you can find on the market meet the required safety standards. Even when masks do meet the minimum standards required by regulatory agencies, they may not provide you with maximum protection against COVID-19 and other airborne illnesses.


So, this begs the question: which safety mask offers the best protection? Let’s evaluate the options to find out:

Cloth Masks


Non-surgical cloth masks are one of the more popular options available, as they are comfortable, reusable, and can even be customized with interesting designs. You can also find cloth masks at just about any retail store, especially larger retailers. For those who want to stick to a budget, cloth masks are a great option, as they can even be created from household materials. However, we recommend using the Center for Disease Control and Prevention (CDC) guidelines if you plan to make your own cloth mask.


So, are cloth masks safe? Yes and no. The protection supplied by a cloth mask will depend on a few different factors. Was the cloth mask produced using tightly-knit cotton? Does it have two or more layers of protection? Does it cover the entire mouth and nose? Is there an extra pocket in which to put single-use filters? 


If the answer to all of these questions is ‘yes,’ then the mask likely provides a moderate to high level of protection. Tightly-woven cloth masks with at least two layers (preferably three) that cover the entirety of the mouth and nose are the best options. Additionally, many cloth masks allow for separate filters to be inserted, providing even greater particle filtration. According to the World Health Organization (WHO), cloth mask efficacy can range anywhere from 1%-70%, depending on the factors outlined above.   

Face Coverings


In addition to traditional cloth masks, there are a number of non-mask alternatives. For example, many people use scarves, neck gaiters, balaclavas, and other cloth coverings to protect their mouth and nose. However, it’s nearly impossible to test the efficacy of these coverings as it can vary based on the material and even how they are worn. That said, a Duke University study shows that these solutions are highly ineffective in general.


One of the main reasons that alternative face coverings are ineffective is because they were never designed to filter out particles or repel fluid. As a result, many cloth coverings are loosely-woven, leaving open pockets for particles to enter. Additionally, they do not have any kind of proper filtration system.

Face Shields


Face shields are utilized by medical personnel and regular consumers alike, often in conjunction with some form of face mask. Though face shields are effective against fluid splatter, they provide absolutely no filtration. This means that particles of any size can reach your mouth and nose from underneath the shield. Thus, face shields should only be used as an added layer of protection. In fact, the CDC has stated that, as long as you wear some kind of face mask, a face shield is largely unnecessary

Surgical Masks


So far, the only type of face covering that is recommended by the CDC and other regulatory agencies is a high-quality, multi-layered cloth mask. However, there are better options. Medical grade surgical masks, like the ASTM Level 3 mask, are ideal for healthcare workers and people who have no choice but to travel or be around others. An ASTM Level 3 mask is a form of surgical mask that provides optimum filtration and protection from fluid splatter.


As the name implies, surgical masks were designed for surgeons to be protected from bacteria and fluid splatter during surgery. They are generally much more effective than cloth masks, as they are made from a non-woven, double-layered material that repels fluids and absorbs large airborne particles. However, surgical masks cannot provide 100% protection from airborne particles. Additionally, just like cloth masks, surgical masks can vary in efficacy.


There are essentially three types of medical-grade masks based on ASTM standards: Level 1, Level 2, and Level 3. An ASTM Level 1 mask can filter out as much as 95% of bacteria and particles. These are designed for short procedures and are not ideal for protecting against strong aerosols and fluid splatter (like a cough or sneeze directly to the face). 


The next step up in protection is the ASTM Level 2 mask. This type of surgical mask provides as much as 98% filtration for bacteria and particles, while also providing greater protection from airborne liquids. ASTM Level 2 masks are common in many hospitals and medical facilities.


Finally, there is the ASTM Level 3 mask. This is the highest grade surgical mask (short of a respirator) for filtration. However, it is not a huge step up from the Level 2 mask. It also provides up to 98% filtration and significant protection against fluid splatter. However, it is the highest graded surgical mask and is therefore the first choice of mask for most healthcare workers.

Respirators


Respirators like the N95 (sometimes known as a N95 mask), N99, and N100 are the top-of-the-line PPE. They provide maximum protection against COVID-19, but they are in short supply. As a result, these respirators are reserved for medical personnel only. 

What Are the FDA Standards for the ASTM Level 3 Mask?


Now that you know your options for protection, it’s time to see why the ASTM Level 3 mask is considered one of the best options for healthcare workers and the best option for regular consumers. In addition to ASTM’s regulatory standards, the FDA has certain requirements for all ASTM Level 3 masks:


  • “The user contacting components of the device must be demonstrated to be biocompatible.
  • Analysis and nonclinical testing must:
    • Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
    • Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
  • NIOSH approved under its regulation.”

In other words, ASTM Level 3 masks (and similar PPE) must meet four FDA requirements. First, the mask must be biocompatible. This means that it is non-toxic and will not cause harm to living tissue. Next, the mask must go through testing to ensure that it meets safety standards for flammability (standards vary by the environment and intended use). 


Then — and perhaps most importantly — the mask must resist the penetration of fluids at varying degrees of velocity. Finally, the mask must be approved by the National Institute for Occupational Safety and Health (NIOSH). The NIOSH ensures that work-related equipment and materials meet certain standards. In the case of face masks, the NIOSH tests them to ensure that they provide the necessary protection for healthcare workers.


It’s important to note that these are just the basic requirements of the FDA for safety masks. Surgical masks like the ASTM Level 3 mask and N95 mask must meet even more specific criteria, including:


  • Composition - All surgical masks must be made of spunbonded, meltblown, or wetlaid polypropylene. 
  • Fluid Penetration Resistance - All surgical masks must undergo a pass/fail test to demonstrate resistance to fluids at velocities that reflect human blood pressure (80, 120, and 160 mm Hg)
  • Filtration Efficiency - All surgical masks must pass a test using 0.1-micron polystyrene latex spheres.
  • Bacterial Filtration Efficiency - All surgical masks must pass the BFE test based on specifications set out by ASTM.
  • Differential Pressure Test - All surgical masks must meet ASTM standards related to the resistance to airflow through the mask.

Conclusion


As you can see, the ASTM Level 3 mask must undergo various tests and meet the requirements of multiple regulatory agencies — including the FDA — before it can be sold to consumers. Based on studies from the CDC and other health related agencies, criteria for mask clearance are set by the ASTM, NIOSHA, and the FDA. This ensures that all surgical masks provide the best possible protection for healthcare workers and regular consumers. Needless to say, this is particularly important when an airborne virus like COVID-19 is spreading through the population. Fortunately, you can easily find the ASTM Level 3 mask for sale at in-person or online retailers, as well as your local pharmacy.