K222426 is an FDA 510(k) clearance for the Perfetta Moderate Medical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Phu Bao Group Company Limited (Ho Chi Minh, VN). The FDA issued a Cleared decision on September 2, 2022, 22 days after receiving the submission on August 11, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K222426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2022 |
| Decision Date | September 02, 2022 |
| Days to Decision | 22 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 |