K212726 is an FDA 510(k) clearance for the Disposable Medical Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Hubei Huaqiang High-Tech Co., Ltd. (Yichang, CN). The FDA issued a Cleared decision on March 23, 2022, 208 days after receiving the submission on August 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2021 |
| Decision Date | March 23, 2022 |
| Days to Decision | 208 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 |