510(k) K093189
K093189 is an FDA 510(k) premarket notification submitted by Glaxosmithkline Consumer Healthcare for the device "ACTIPROTECT UC N95 RESPIRATOR". The FDA issued a decision of Substantially Equivalent on July 2, 2010. The device falls under product code ORW (N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies), a Class II device regulated under 21 CFR 880.6260. Glaxosmithkline Consumer Healthcare has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2010
- Date Received
- October 9, 2009
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
- Device Class
- Class II
- Regulation Number
- 880.6260
- Review Panel
- HO
- Submission Type
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.