The following data is part of a premarket notification filed by Guangdong Winsun Personal Care Products Co.,ltd with the FDA for Surgical Face Mask.
| Device ID | K210023 |
| 510k Number | K210023 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Guangdong Winsun Personal Care Products Co.,Ltd No.1 Guangxing Road, Xiqiao Sci-Tec Industrial Park, Xiqiao Town Foshan, CN 528200 |
| Contact | Dong Pingping |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-04-02 |