The following data is part of a premarket notification filed by Hubei Wanli Protective Products Co. Ltd with the FDA for Surgical Gown.
| Device ID | K211509 |
| 510k Number | K211509 |
| Device Name: | Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Hubei Wanli Protective Products Co. Ltd Tangwan Street, Xiliuhe Town Xiantao, CN |
| Contact | Andy Wen |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, CN 200122 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-14 |
| Decision Date | 2021-10-24 |