K223045 is an FDA 510(k) clearance for the 3-Ply Disposable Medical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Wealth Lead Industrial Limited (Hong Kong, CN). The FDA issued a Cleared decision on December 7, 2022, 69 days after receiving the submission on September 29, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K223045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2022 |
| Decision Date | December 07, 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 |