FDA product code ONT

N95 Respirator With Antimicrobial/Antiviral Agent

General, Plastic Surgery·Class 2·21 CFR 878.4040
US regulatory classifications
US Product Code (FDA)
ONT
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4040
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

N95 Respirator With Antimicrobial/Antiviral Agent is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.