As face masks are becoming more of a necessity for people around the world — and not just physicians and health-care professionals fighting the coronavirus — the purposes they serve are as varied as the individuals who wear them. Part of the increasing demand for masks stems from the fact that surgical masks and N95 respirators are not meant to be shared or reused.
The widely referenced N95 respirators and surgical masks are examples of personal protective equipment used to protect wearers from airborne particles and from liquid contaminating the face. In addition to the U.S. Food and Drug Administration, the regulation of N95 respirators in the U.S. is handled by the Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health and the Occupational Safety and Health Administration. The criteria for various medical face masks include material performance testing for bacterial filtration efficiency, differential, pressure resistance to synthetic blood, flammability and submicron particulate filtration efficiency.
With essential PPE scarce in many health facilities due to the COVID-19 crisis, the FDA recently lifted requirements for different masks to increase availability. For example, face masks that are to be used for medical purposes but are not meant to provide a liquid barrier, no longer need 510(k) submission clearance, quality system regulation, registration and listing, and unique device identifier requirements, as long as the devices do not create an undue risk for users.
Face masks and respirators designed for general or industrial use and not medical purposes are not subject to FDA requirements outlined in the Federal, Food, Drug and Cosmetic Act.
In its most basic definition, a face mask is a mask with or without a face shield that covers the nose and mouth, and may or may not meet fluid barrier and filtration efficiency levels based.
A face shield is a device used to protect the eyes and face from bodily fluids, liquid splashes or potentially infectious materials.
A surgical mask is a loose-fitting disposable device that provides a barrier between the mouth and nose of the wearer and potential contaminants in the environment.
An N95 respirator is a respiratory protective device with a close facial fit and efficient filtration of airborne particles. As is the case with surgical masks, they are tested for fluid resistance, particulate and bacterial filtration efficiencies, flammability and biocompatibility.
Surgical N95 respirators are commonly used in hospitals and other health-care settings and are a subset of Filtering Facepiece respirators, which are often referred to as N95s. Surgical N95 respirators are disposable FFRs that are used in health-care facilities to protect patients and health-care providers from the transfer of microorganisms, body fluids and particulate material at an N95 filtration level per 42 CFR 84.181.
A Filtering Facepiece respirator is a disposable half-face piece with a nonpowered air-purifying particulate respirator designed to help reduce wearers’ exposure to pathogenic biological airborne particulates.
A NIOSH Approved N95 respirator meets filtration efficiency level per CFR 84.181.
To try to extend the supply chain as the pandemic continues to sweep through the U.S., the FDA has indicated it is interested in allowing companies to disinfect and reprocess disposable N95 respirators via an emergency use authorization.