The following data is part of a premarket notification filed by Jiangsu Province Jianerkang Medical Dressing Co., Ltd with the FDA for Surgical Gowns.
| Device ID | K210215 |
| 510k Number | K210215 |
| Device Name: | Surgical Gowns |
| Classification | Gown, Surgical |
| Applicant | Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town Changzhou, CN 213251 |
| Contact | Tang Hongfang |
| Correspondent | Tang Hongfang Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town Changzhou, CN 213251 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-27 |
| Decision Date | 2021-07-07 |