The following data is part of a premarket notification filed by Taizhou Donghaixiang Protective Equipment Co., Ltd with the FDA for Dong Hai Xiang Surgical Mask.
| Device ID | K212203 |
| 510k Number | K212203 |
| Device Name: | Dong Hai Xiang Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Taizhou Donghaixiang Protective Equipment Co., Ltd No.3091 Dunan Road Duqiao Town Linhai, CN 317016 |
| Contact | Hong Wei |
| Correspondent | Shuai Wang Getilapson (Dalian) Biological Technology Co., Ltd RM. 408 NO. 207, Zhongnan Rd Dalian, CN 116001 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-14 |
| Decision Date | 2022-04-07 |