K202655 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 Dongguan Runlin Medical Supplies Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on April 5, 2021, 203 days after receiving the submission on September 14, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2020 |
| Decision Date | April 05, 2021 |
| Days to Decision | 203 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 |