The following data is part of a premarket notification filed by Wujiang Tutaike Textiles & Finishing Co., Ltd. with the FDA for Surgical Gown.
| Device ID | K213703 |
| 510k Number | K213703 |
| Device Name: | Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Wujiang Tutaike Textiles & Finishing Co., Ltd. No.1599, South 3rd Ring Road, Shengze, Wujiang Suzhou, CN 317605 |
| Contact | Zhang Yanwen |
| Correspondent | Kevin Chen Shanghai Mil-medshare Medical Technology Co., Ltd Shanghai, CN |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-24 |
| Decision Date | 2022-03-04 |