NZJ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6260

Medical specialty

General Hospital

FDA 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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