What does the FDA say about the filtration efficacy of N95 masks?

During the coronavirus pandemic, the N95 has managed to remain the product of choice by all, especially the healthcare professionals. The chief reason behind the N95’s stature is its efficient defense against all airborne particulates. The approval of esteemed US authorities like the FDA, CDC, NIOSH, and OSHA also serves as a testament to its efficiency. An N95 respirator has been tried and tested by these authorities and was found to fit the criteria that are prescribed for such a respirator, which is also going to be used by the frontline workers.

N95 for healthcare workers

The Food and Drug Administration agency along with CDC recommends N95s specifically for frontline workers due to their innovative functionality and design that ensures optimum protection for its user. This disposable respirator is created by using non-woven polypropylene material acquired through the process of melt blowing and is not protective against gases or vapors. Among all other N95 features, the few that stand out the most and distinguishes it from various other respirators include the tight seal fit that serves as a barrier and halts particulates from entering the mask through small spaces, the filter’s 95% efficient protection against fluids, bacteria, and viruses up-to-the size of 0.3 microns and its approval by FDA and NIOSH which is further marked by a NIOSH logo on the respirator.

The N95 used in healthcare settings is a special type of N95 which is classified under the class 2 devices as per the FDA regulations and is referred to as the ‘surgical N95’. A surgical N95 is used during medical procedures and ensures the safety of both patient and the personnel and is strictly advised to be discarded after each use due to exposure to a highly contaminated environment.

Strategy for reusing respirators prescribed by the FDA

The FDA has also issued a notice for the reuse of N95 respirators which is known as the EUAs (Emergency Use Authorizations) which allows hospitals to decontaminate FDA and NIOSH-approved respirators to curb the scarcity of N95s in healthcare. A new respirator is always preferable over a used one, however, under extreme and dire circumstances which have emerged during the coronavirus pandemic the FDA has allowed the reuse of certain N95 respirators after decontaminating it from a EUA approved decontamination system. This reuse strategy is only recommended if new and unused respirators are not available and if the decontamination is permitted by the manufacturer.

Importance of the approval by FDA for an N95

Besides the N95 masks, there are some other respirators considered to be the equivalent of an N95 and work similarly as well. Some close substitutes to be named are—the KN95 and the FFP2. However, these masks are not regulated by the FDA and do not fit the criteria of a suitable and reliable mask that the FDA demands from manufacturers. Since FDA is a relevant agency dealing with matters related to public health, the approving and disapproving of respirators is a matter of concern for them. Therefore, their approval speaks for itself as their rigorous method of testing and deciding on approval for a mask is meticulous and can be completely relied on.

To conclude, the fact that N95 is the only respirator that is approved by the FDA, CDC, NIOSH, and OSHA means that there should be no doubt about the efficacy of an N95 mask. There are various types of N95 respirators being produced by different manufacturers. The FDA has also issued a list of all verified manufacturers who are authentic and produce original N95 respirators to put a halt to the selling and purchasing of counterfeit respirators.

Precautions for using the N95

There are some guidelines on using an N95 respirator that has been issued by the FDA. These guidelines contain information on the proper way of using an N95 respirator and also provide precautionary measures. According to the FDA prescribed guideline, an N95 is not suitable for children or people with facial hair. The respirator is also not recommended for people who have a history of heart diseases and should only use it if approved by their doctor. If a respirator becomes damaged, soiled, difficult to breathe in, or reaches its expiration date then it should be discarded and that too properly.

In addition, N95 masks with valves are not recommended by the FDA. The valved N95’s should especially not be used during the ongoing pandemic as the valves push the exhaled air outwards which then travels far and is inhaled by others at one point or another. Therefore, these particular masks ruin the actual purpose of a mask for all parties and they are also not recommended to be used after sterilization.


FDA is a federal agency of the United States that is primarily concerned with the health matters prevailing in the country. Some other agencies like the NIOSH, CDC, and OSHA also work with FDA in collaboration for the same objective. The N95 respirator is approved by all these agencies to be used in both healthcare and construction settings. It can also be used by the general public who aren’t associated with any of these professions but during the pandemic, the public was advised to not use this mask as they were crucial for the healthcare workers and were available in a very scarce quantity. N95s is the only respirator to be approved by all agencies and is the most efficient piece of PPE when seeking protection against any airborne particulates.

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