The following data is part of a premarket notification filed by Qinghai Zhong Dao Win-win Medical Protective Equipment Co., with the FDA for Disposable Medical Face Mask.
| Device ID | K202628 |
| 510k Number | K202628 |
| Device Name: | Disposable Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Qinghai Zhong Dao Win-win Medical Protective Equipment Co., No.36 Jingsan Road, Biological Park Xining, CN 810000 |
| Contact | Zhaochu Chen |
| Correspondent | Shelley Li Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, CN 200071 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2021-03-19 |