510(k) K150729
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2015
- Date Received
- March 20, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- N95 Respirator With Antimicrobial/Antiviral Agent
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.