K180874 is an FDA 510(k) clearance for the 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on July 31, 2018, 119 days after receiving the submission on April 3, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K180874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2018 |
| Decision Date | July 31, 2018 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |