Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
The Respirator, N95, For Use By The General Public In Public Health Medical Emergencies (product code NZJ) is an N95-rated respirator intended to cover the nose and mouth to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies such as an influenza pandemic, while also protecting against splash and spray of body fluids. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 880.6260 within the General Hospital specialty. The device carries no implant or life-sustaining flags.
Basic Information
- Product Code
- NZJ
- Device Class
- FDA class 2
- Regulation Number
- 880.6260
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.