K202128 is an FDA 510(k) clearance for the Allmed Surgical Face Masks (Ear loops). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Allmed Medical Products Co., Ltd. (Zhijiang, CN). The FDA issued a Cleared decision on June 3, 2021, 307 days after receiving the submission on July 31, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2020 |
| Decision Date | June 03, 2021 |
| Days to Decision | 307 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 |