ORW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6260
- Medical specialty
- General Hospital
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ACTIPROTECT UC N95 RESPIRATOR (K093189) | Glaxosmithkline Consumer Healthcare | 2010-07-02 | + Add |
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