The following data is part of a premarket notification filed by Xiantao Dingcheng Non-woven Product Co., Ltd with the FDA for Surgical Gowns.
| Device ID | K212718 |
| 510k Number | K212718 |
| Device Name: | Surgical Gowns |
| Classification | Gown, Surgical |
| Applicant | Xiantao Dingcheng Non-Woven Product Co., Ltd Liukou Industrial Park Xiantao, CN 433099 |
| Contact | Cheng Qin |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-27 |
| Decision Date | 2022-01-12 |