K150729 is an FDA 510(k) clearance for the SpectraShield 9500 Surgical N95 Respirator. This device is classified as a N95 Respirator With Antimicrobial/antiviral Agent (Class II - Special Controls, product code ONT).
Submitted by Nexera Medical, Inc. (Ft.Lauderdale, US). The FDA issued a Cleared decision on December 29, 2015, 284 days after receiving the submission on March 20, 2015.
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 | K150729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2015 |
| Decision Date | December 29, 2015 |
| Days to Decision | 284 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. |