K213601 is an FDA 510(k) clearance for the Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Wuhan Zonsen Medical Products Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on December 16, 2022, 396 days after receiving the submission on November 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K213601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2021 |
| Decision Date | December 16, 2022 |
| Days to Decision | 396 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 |