NZJ

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

Product code

NZJ

Device name

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

Device class

Class 2

21 CFR

21 CFR 880.6260

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification 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.

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