K202137 is an FDA 510(k) clearance for the Disposable medical mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by U-Play Products Corporation (Wuhu, CN). The FDA issued a Cleared decision on March 4, 2021, 216 days after receiving the submission on July 31, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2020 |
| Decision Date | March 04, 2021 |
| Days to Decision | 216 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 |