The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Co., Ltd. with the FDA for Single-use Medical Face Mask.
| Device ID | K210622 |
| 510k Number | K210622 |
| Device Name: | Single-Use Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangxi Hongda Medical Equipment Group Co., Ltd. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, China Nanchang, CN 331700 |
| Contact | Xiaohua Yang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-02 |
| Decision Date | 2021-10-08 |