K211794 is an FDA 510(k) clearance for the Disposable surgical mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Shanghai No.9 Knitting Mill Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 28, 2021, 110 days after receiving the submission on June 10, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2021 |
| Decision Date | September 28, 2021 |
| Days to Decision | 110 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 |