K220597 is an FDA 510(k) clearance for the Disposable Surgical Face Mask (FM-34EE,FM-44EE). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on May 26, 2022, 86 days after receiving the submission on March 1, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K220597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2022 |
| Decision Date | May 26, 2022 |
| Days to Decision | 86 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 |