K211631 is an FDA 510(k) clearance for the Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Macheng Thimble Technology Investment Co., Ltd. (Huanggang, CN). The FDA issued a Cleared decision on August 18, 2021, 83 days after receiving the submission on May 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2021 |
| Decision Date | August 18, 2021 |
| Days to Decision | 83 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 |