K081923 is an FDA 510(k) clearance for the ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD. This device is classified as a N95 Respirator With Antimicrobial/antiviral Agent (Class II - Special Controls, product code ONT).
Submitted by Glaxosmithkline Consumer Healthcare (Parsippany, US). The FDA issued a Cleared decision on July 1, 2009, 359 days after receiving the submission on July 7, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040. 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..
| 510(k) Number | K081923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2008 |
| Decision Date | July 01, 2009 |
| Days to Decision | 359 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | ONT — N95 Respirator With Antimicrobial/antiviral Agent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
| Definition | 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. |