# Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NZJ)
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