K220824 is an FDA 510(k) clearance for the Medical Surgical Mask (Planar type). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Hunan Chopard Medical Devices Co., Ltd. (Liuyang, CN). The FDA issued a Cleared decision on May 19, 2022, 59 days after receiving the submission on March 21, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K220824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2022 |
| Decision Date | May 19, 2022 |
| Days to Decision | 59 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 |