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

NZJ · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6260

Classification

FDA Product Code: NZJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.6260
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 11

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown