K201718 is an FDA 510(k) clearance for the GD Disposable Medical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Jiangsu Guangda Medical Material Group Co., Ltd. (Libao Town, CN). The FDA issued a Cleared decision on April 15, 2021, 296 days after receiving the submission on June 23, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2020 |
| Decision Date | April 15, 2021 |
| Days to Decision | 296 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 |