ORW — N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies Class II
FDA product code ORW covers "N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies", a Class II medical device regulated under 21 CFR 880.6260. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ORW
- Device Class
- Class II
- Regulation Number
- 880.6260
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies 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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093189 | glaxosmithkline consumer healthcare | ACTIPROTECT UC N95 RESPIRATOR | July 2, 2010 |