K212649 is an FDA 510(k) clearance for the Disposable Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Lyncmed Medical Technology (Beijing) Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 25, 2022, 428 days after receiving the submission on August 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2021 |
| Decision Date | October 25, 2022 |
| Days to Decision | 428 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 |