K221273 is an FDA 510(k) clearance for the Medical Face Mask (M001). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Xingyu Medical Tech Co., Ltd. (Weifang, CN). The FDA issued a Cleared decision on June 28, 2022, 57 days after receiving the submission on May 2, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K221273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2022 |
| Decision Date | June 28, 2022 |
| Days to Decision | 57 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 |