K203112 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 Yangzhou Runyi Arts & Crafts Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on September 16, 2021, 336 days after receiving the submission on October 15, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2020 |
| Decision Date | September 16, 2021 |
| Days to Decision | 336 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 |