K212293 is an FDA 510(k) clearance for the Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Jiangmen Ningrui Medical Supplies Co., Ltd. (Taishan, CN). The FDA issued a Cleared decision on October 25, 2021, 95 days after receiving the submission on July 22, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2021 |
| Decision Date | October 25, 2021 |
| Days to Decision | 95 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 |