The following data is part of a premarket notification filed by Wuhan Zonsen Medical Products Co., Ltd with the FDA for Surgical Isolation Gown.
| Device ID | K212357 |
| 510k Number | K212357 |
| Device Name: | Surgical Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District Wuhan, CN 431000 |
| Contact | Cynthia Ye |
| Correspondent | Cynthia Ye Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District Wuhan, CN 431000 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-29 |
| Decision Date | 2022-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850044458855 | K212357 | 000 |
| 20850044458848 | K212357 | 000 |
| 20850044458831 | K212357 | 000 |
| 20850044458824 | K212357 | 000 |
| 20850044458817 | K212357 | 000 |
| 20850044458800 | K212357 | 000 |
| 20850044458794 | K212357 | 000 |