K202794 is an FDA 510(k) clearance for the Surgical face mask: F-Y1-A. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Jiande Chaomei Daily Chemicals Co., Ltd. (Jiande, CN). The FDA issued a Cleared decision on December 13, 2021, 446 days after receiving the submission on September 23, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2020 |
| Decision Date | December 13, 2021 |
| Days to Decision | 446 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 |