The following data is part of a premarket notification filed by Allmed Medical (hubei) Protective Products Co., Ltd with the FDA for Isolation Gown (s, M, L, Xl, Xxl (yellow, Blue)).
| Device ID | K221027 |
| 510k Number | K221027 |
| Device Name: | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) |
| Classification | Gown, Isolation, Surgical |
| Applicant | Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China Zhijiang, CN 443299 |
| Contact | Vince Tian |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-06 |
| Decision Date | 2022-08-12 |