The following data is part of a premarket notification filed by Allmed Medical (hubei) Protective Products Co., Ltd with the FDA for Surgical Gown (sterile); Surgical Gown (non-sterile).
| Device ID | K221637 |
| 510k Number | K221637 |
| Device Name: | Surgical Gown (Sterile); Surgical Gown (Non-sterile) |
| Classification | Gown, Surgical |
| Applicant | Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town Zhijiang, CN 443203 |
| Contact | Vince Tian |
| Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Central Avenue 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 | 2022-06-06 |
| Decision Date | 2022-09-29 |