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 (last 3 years): 6

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).

Official FDA classification page: ONT

Classification and pathway per current FDA publications. Data from openFDA (CC0).