K210150 is an FDA 510(k) clearance for the Disposable Medical mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Hubei Wanli Protective Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on June 2, 2021, 132 days after receiving the submission on January 21, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2021 |
| Decision Date | June 02, 2021 |
| Days to Decision | 132 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 |