K221222 is an FDA 510(k) clearance for the Surgical Face Mask (HNFM0304). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Shanghai Hua EN Industrial Co, Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 6, 2022, 40 days after receiving the submission on April 27, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K221222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2022 |
| Decision Date | June 06, 2022 |
| Days to Decision | 40 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 |