K213736 is an FDA 510(k) clearance for the Medical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Hangzhou Runheng Medical Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 31, 2022, 122 days after receiving the submission on November 29, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K213736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2021 |
| Decision Date | March 31, 2022 |
| Days to Decision | 122 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 |