K223068 is an FDA 510(k) clearance for the Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Guangdong Golden Leaves Technology Development Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on November 23, 2022, 54 days after receiving the submission on September 30, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K223068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2022 |
| Decision Date | November 23, 2022 |
| Days to Decision | 54 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 |