Since the COVID-19 pandemic began in 2020, face masks have become available at nearly every online and brick & mortar retailer. Everything from reusable cloth masks to protective face masks labeled ‘medical masks’ are widely available. The question is; are medical-grade face masks better than face masks you can buy at a gas station or grocery store?
There are differences between regular protective face masks and medical-grade face masks which can be hard to spot. Many cheap masks label themselves disingenuously as ‘medical’ in one way or another, but how can you tell the difference between fakes and real medical-grade masks?
Our pharmacists have been working on securing medical-grade face masks since the COVID-19 pandemic began. Over time we have learned which medical-grade masks are worth investing in to keep you, your family, and those around you safe.
Medical Mask Grades
Actual FDA-approved (or FDA EUA–emergency use authorization) medical masks are graded by the ASTM (American Society for Testing and Materials) on their protection levels. The most common grades associated with consumer protective face masks are levels 1, 2, & 3, and N95 masks.
ASTM International sets the preferred international standard in healthcare for best practices inclusive of testing and requirements for the performance of materials. The FDA, which oversees the sale and marketing of all surgical masks, recommends that manufacturers demonstrate mask performance in 4 areas:
- Fluid Resistance
- Differential Pressure
- Filter Efficiency
- Flammability
What does each level mean?
Level 1 Medical Grade Face Masks
The ASTM classifies low-barrier protection masks as level 1. In medical settings level 1 masks are used for short procedures and exams that don’t involve aerosols, spray, or fluids. Level 1 masks are the baseline for entry into the medical grade mask category.
Level 1 facemasks work fine for most situations where you are looking to keep yourself and others safe in sparsely populated social situations.
Level 2 Medical Grade Face Masks
The ASTM classifies moderate barrier protection masks as level 2. In medical settings level 2 masks are used during procedures with low to moderate levels of aerosols, spray, and/or fluids. Level 2 medical-grade face masks provide superior protection and barrier entry compared to level 1 masks.
Level 2 facemasks are much better than level 1 masks for more hazardous situations like a visit to your doctor or other healthcare facilities.
Level 3 Medical Grade Face Masks
The ASTM classifies maximum barrier protection masks as level 3. In medical settings level 3 masks are used during procedures with heavy levels of aerosols, spray, and/or fluids.
Differences Between Level 1,2, & 3 Medical Grade Face Masks
The chief difference between level 1 and level 2 & 3 masks primarily deals with bodily fluids. Level 2 & 3 masks are used for complex medical procedures and were designed to keep fluids from making significant contact with the nose or mouth.
The risk of exposure to bodily fluids in crowded situations can be significant and the protection offered by an ASTM Level 1 mask is minimal. When the risk is unknown or too great to ignore, level up your mask selection and get better protection with a level 2 or 3 mask.
The difference in protection between a Level 2 mask and a Level 3 mask is minimal. Level 3 medical-grade face masks do offer slightly better protection & barrier resistance, so if you are on the fence go with level 3 masks.
N95 Face Masks
N95 face masks are actually classified as respirators, as they efficiently filter many airborne particles. Unlike level 1-3 medical-grade masks, N95 respirators are primarily designed for hazardous construction work. While the ASTM classifies level 1-3 masks, the NPPTL (National Personal Protective Technology Laboratory) & NIOSH (National Institute for Occupational Safety and Health), which are both parts of the CDC.
The FDA classifies N95 masks as “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.”
The FDA also classifies some N95 masks as class II, which means they are safe for use in medical settings. 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
- 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
- The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms)
Why is it Important to Get Medical Grade Face Masks?
While no mask will effectively filter out every dangerous particle, FDA-certified medical face masks have actually been tested and approved. Many uncertified face masks are simply face coverings that will only filter large things like spit and snot.
The FDA notes that “While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, 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.”
Do Not Reuse Medical Grade Face Masks
Medical-grade face masks are designed to be used once. Masks can be contaminated by any environment you visit and it is implied that they are to be thrown away after use. Reusing medical-grade masks can be dangerous to your health.
How to Make Sure Your Masks are Medical Grade
If you want to be sure the masks you are buying are medical-grade, the first step is to carefully read the box. If you are still unsure, googling the brand or any certifications printed on the box can help. It is not recommended to buy masks from random online dealers as their masks may not match the description.
If you are in a retail store, especially a medical supply store or pharmacy, the best way to get information about masks is to ask!
Our pharmacists have been working with our medical supply team for over a year now to ensure we stock a quality selection of medical-grade & N95 protective masks. Our team knows the differences between mask levels and brands and would be happy to answer any questions you may have.
If you want to know more or talk to one of our medical supply team members, send us an email or give us a call. We’re here to help you and your family.