The following data is part of a premarket notification filed by Jiangxi Heying Pharmaceutical Co., Ltd with the FDA for Disposable Surgical Face Mask.
| Device ID | K210429 |
| 510k Number | K210429 |
| Device Name: | Disposable Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangxi Heying Pharmaceutical Co., Ltd Huangjinbu Town, Yugan County Shangrao, CN 335100 |
| Contact | Junzheng Liu |
| Correspondent | Mandy Wu Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-12 |
| Decision Date | 2021-06-02 |