K231741 is an FDA 510(k) clearance for the ProGear® Surgical Mask with Oxafence®, Model AV82030. This device is classified as a Surgical Mask With Antimicrobial/antiviral Agent (Class II - Special Controls, product code OUK).
Submitted by Prestige Ameritech (North Richland Hills, US). The FDA issued a Cleared decision on September 5, 2024, 449 days after receiving the submission on June 14, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040. A Single Use, Disposable Surgical Mask For Occupational Use To Cover The Nose And Mouth Of The Wearer To Protect From The Transfer Of Microorganisms,body Fluids And Particulates And Has An Added Antimicrobial And/or Antiviral Agent Which Kills Specific Pathogens Under Specified Contact Conditions..
| 510(k) Number | K231741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2023 |
| Decision Date | September 05, 2024 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | OUK - Surgical Mask With Antimicrobial/antiviral Agent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
| Definition | A Single Use, Disposable Surgical Mask For Occupational Use To Cover The Nose And Mouth Of The Wearer To Protect From The Transfer Of Microorganisms,body Fluids And Particulates And Has An Added Antimicrobial And/or Antiviral Agent Which Kills Specific Pathogens Under Specified Contact Conditions. |