K211696 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 Anhui Cleanpro Pharmpack Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on November 30, 2021, 181 days after receiving the submission on June 2, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2021 |
| Decision Date | November 30, 2021 |
| Days to Decision | 181 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 |