K093189 is an FDA 510(k) clearance for the ACTIPROTECT UC N95 RESPIRATOR. This device is classified as a N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies (Class II - Special Controls, product code ORW).
Submitted by Glaxosmithkline Consumer Healthcare (Parsippany, US). The FDA issued a Cleared decision on July 2, 2010, 266 days after receiving the submission on October 9, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6260. 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..
| 510(k) Number | K093189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2009 |
| Decision Date | July 02, 2010 |
| Days to Decision | 266 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | ORW — N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6260 |
| 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. |