K122702 is an FDA 510(k) clearance for the BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR. This device is classified as a N95 Respirator With Antimicrobial/antiviral Agent (Class II - Special Controls, product code ONT).
Submitted by Filligent Limited (Hong Kong, CN). The FDA issued a Cleared decision on March 18, 2013, 195 days after receiving the submission on September 4, 2012.
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 | K122702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2012 |
| Decision Date | March 18, 2013 |
| Days to Decision | 195 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. |