K202676 is an FDA 510(k) clearance for the Disposable Medical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Zhejiang Senhong Medical&Instrument Co., Ltd. (Huzhou, CN). The FDA issued a Cleared decision on November 5, 2021, 416 days after receiving the submission on September 15, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2020 |
| Decision Date | November 05, 2021 |
| Days to Decision | 416 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 |