The following data is part of a premarket notification filed by Jiangsu Guangda Medical Material Group Co., Ltd. with the FDA for Gd Disposable Medical Face Mask.
| Device ID | K201718 |
| 510k Number | K201718 |
| Device Name: | GD Disposable Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu Guangda Medical Material Group Co., Ltd. No. 18 Baochang Road (North) Libao Town, CN |
| Contact | George Zhang |
| Correspondent | W. Victoria Rogers Rogers Consulting 11110 Arranmore Cove Roanoke, IN 46783 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2021-04-15 |