FDA product code NZJ

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

General Hospital·Class 2·21 CFR 880.6260
US regulatory classifications
US Product Code (FDA)
NZJ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.6260
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.

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About this record

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies is a medical device type in the General Hospital 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.