K222266 is an FDA 510(k) clearance for the Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Jingzhou Haixin Green Cross Medical Products Co., Ltd. (Jingzhou, CN). The FDA issued a Cleared decision on September 26, 2022, 60 days after receiving the submission on July 28, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K222266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2022 |
| Decision Date | September 26, 2022 |
| Days to Decision | 60 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 |