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 | K211077 |
| 510k Number | K211077 |
| 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 | Eva Li Microkn Business Consulting (Shanghai) Co., Ltd Room 1215, Block A, No 3699, Gonghexin Road, Jingan District 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 | 2021-04-12 |
| Decision Date | 2021-10-07 |