The following data is part of a premarket notification filed by Jiangsu Province Jianerkang Medical Dressing Co., Ltd with the FDA for Medical Face Mask.
| Device ID | K202061 |
| 510k Number | K202061 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town, Jintan Changzhou, CN 213251 |
| Contact | Hongfang Tang |
| Correspondent | Hongfang Tang Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town, Jintan Changzhou, CN 213251 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2020-12-23 |