K222697 is an FDA 510(k) clearance for the Disposable Medical Face Mask (DF3-001). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Wellmed Dental Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 4, 2022, 58 days after receiving the submission on September 7, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K222697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 58 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 |