An N95 respirator is a disposable filtering facepiece respirator or reusable elastomeric respirator filter that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 standard of air filtration, filtering at least 95% of airborne particles that have a mass median aerodynamic diameter of 0.3 micrometers under 42 CFR 84, effective July 1995.
A surgical N95 is also rated against fluids, and is regulated by the US Food and Drug Administration under 21 CFR 878.4040, in addition to NIOSH 42 CFR 84. 42 CFR 84, the federal standard which the N95 is part of, was created to address shortcomings in the prior United States Bureau of Mines respirator testing standards, as well as tuberculosis outbreaks, caused by the HIV/AIDS epidemic in the United States. Since then, N95 respirator has continued to be used as a source control measure in various pandemics that have been experienced in the United States and Canada, including the 2009 swine flu and the COVID-19 pandemic, and has been recommended by the EPA for protection against wildfire smoke.