ONT

N95 Respirator With Antimicrobial/Antiviral Agent

Product code

ONT

Device name

N95 Respirator With Antimicrobial/Antiviral Agent

Device class

Class 2

21 CFR

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification definition

A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.

Definition text from the FDA device classification database (U.S. federal government work, public domain).