K202605 is an FDA 510(k) clearance for the Standard Procedure Mask, Standard Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. (Siyang, CN). The FDA issued a Cleared decision on February 10, 2021, 155 days after receiving the submission on September 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2020 |
| Decision Date | February 10, 2021 |
| Days to Decision | 155 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 |