K211899 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 Hubei Yi-Ya Protective Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on October 4, 2021, 105 days after receiving the submission on June 21, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | October 04, 2021 |
| Days to Decision | 105 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 |