K210487 is an FDA 510(k) clearance for the MIPLNI YK-244 Disposable Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Hunan Yuankang Biological Technology Co., Ltd. (Hengyang, CN). The FDA issued a Cleared decision on March 16, 2021, 25 days after receiving the submission on February 19, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2021 |
| Decision Date | March 16, 2021 |
| Days to Decision | 25 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 |