K222335 is an FDA 510(k) clearance for the Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Luoyang Sunmed Devices Co., Ltd. (Luoyang, CN). The FDA issued a Cleared decision on October 11, 2022, 69 days after receiving the submission on August 3, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K222335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2022 |
| Decision Date | October 11, 2022 |
| Days to Decision | 69 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 |