The U.S. Food and Drug Administration (FDA) only clears N95 respirators certified by the National Institute for Occupational Safety and Health (NIOSH).
The FDA confirms that the respirator has a valid NIOSH certification number and therefore has met the particle filtration efficiency standards and other requirements.
Then the agency looks at whether the product also meets the biocompatibility, flammability, and fluid resistance standards and, if so, the product could be approved as a surgical N95 respirator.
If the surgical N95 respirator is proposed to have an antimicrobial additive, the FDA imposes additional requirements because of the concern that chemically attaching or embedding an antimicrobial could affect a filter’s barrier performance.
NIOSH does not issue a certification of a surgical N95 respirator, until the FDA confirms it is also reviewing the product.