N95 Respirators

Surgical masks and surgical N95 respirators are disposable devices that cover the mouth and nose during medical procedures. They help protect the caregiver and patient against microorganisms, body fluids, and small particles in the air.

Surgical masks and surgical N95 respirators are regulated by the Food and Drug Administration (FDA). FDA evaluates the performance of these devices in areas including fluid resistance and filtration efficiency to ensure that they are at least as safe and effective as similar devices already on the market. FDA encourages manufacturers to follow specific performance standards for their masks, and FDA also requires that these products be produced using good manufacturing practices.

Respirators may also be certified by NIOSH (the National Institute for Occupational Safety and Health) in accordance with regulations in 42 CFR part 84. When a mask is both cleared by FDA as a surgical mask and certified by NIOSH as an N95 respirator mask, FDA calls it a “surgical N95 respirator.”


Note:  Surgical N95 respirators are often recommended for those dealing with swine flu contagion.

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.