Is a Surgical Mask the Same as an N95 Respirator?

No. A surgical mask is a loose-fitting device regulated by FDA as a medical device that mainly protects against splashes and large droplets. An N95 is a tight-fitting respirator approved by NIOSH that filters at least 95 percent of airborne particles when properly fitted. Only respirators count under OSHA's Respiratory Protection standard, which requires fit testing for tight-fitting models.

Surgical masks. FDA regulates surgical masks as medical devices under 21 CFR 878.4040, and NIOSH describes them as Class II medical devices. They are loose-fitting, help block large droplets, splashes and sprays, and reduce the wearer's spread of respiratory secretions. FDA and NIOSH explain that surgical masks are not designed to seal to the face or to reliably protect the wearer from inhaling small airborne particles.

N95 respirators. NIOSH approves respirators under 42 CFR Part 84, and N95 filters must meet a 95 percent minimum efficiency (42 CFR 84.170); the Learn Laws® FAQ on NIOSH-approved respirators covers approval labels and filter classes. A filtering facepiece is a negative pressure particulate respirator under OSHA's definitions (29 CFR 1910.134(b)). A surgical N95 is a NIOSH-approved respirator that FDA also regulates as a medical device.

OSHA consequences.

• When an employer requires N95s or other respirators, the full respiratory protection program applies, including medical evaluation, fit testing before first use and at least annually, and training (29 CFR 1910.134(c), (e), (f), (k)).
• Wearing a surgical mask does not trigger 1910.134, because it is not a respirator.
• Voluntary use of filtering facepieces requires the Appendix D information (1910.134(c)(2)), covered in the live NIOSH respirator FAQ.

CDC practice. CDC airborne precautions call for a fit-tested NIOSH-approved N95 or higher respirator, while droplet precautions call for a mask.

Learn Laws® is a training company, not a law firm. This FAQ is general information, not legal advice.