K212330 is an FDA 510(k) clearance for the Yadu Medical Face Mask (Level 1). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Henan Yadu Industrial Co., Ltd. (Changyuan, CN). The FDA issued a Cleared decision on March 14, 2022, 230 days after receiving the submission on July 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2021 |
| Decision Date | March 14, 2022 |
| Days to Decision | 230 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 |