K220302 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 Shandong Aida Medical Products Co., Ltd. (Weifang, CN). The FDA issued a Cleared decision on November 16, 2022, 287 days after receiving the submission on February 2, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K220302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2022 |
| Decision Date | November 16, 2022 |
| Days to Decision | 287 days |
| Submission Type | Abbreviated |
| 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 |