K231155 is an FDA 510(k) clearance for the Biodegradable Medical surgical mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on November 7, 2023, 197 days after receiving the submission on April 24, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K231155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2023 |
| Decision Date | November 07, 2023 |
| Days to Decision | 197 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 |