The following data is part of a premarket notification filed by Wuhan Dymex Healthcare Co., Ltd. with the FDA for Surgical Isolation Cover Gown.
| Device ID | K220528 |
| 510k Number | K220528 |
| Device Name: | Surgical Isolation Cover Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | Wuhan Dymex Healthcare Co., Ltd. Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5, Dongfeng Avenue Wuhan, CN 430000 |
| Contact | Lynn Wu |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-24 |
| Decision Date | 2022-06-10 |