The following data is part of a premarket notification filed by Hubei Xinxin Non-woven Co.,ltd. with the FDA for Aami4 Isolation Gown.
| Device ID | K214116 |
| 510k Number | K214116 |
| Device Name: | AAMI4 Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | Hubei Xinxin Non-woven Co.,Ltd. Taizihu Industrial Park, Pengchang Town Xiantao, CN 433018 |
| Contact | Nicole Jin |
| 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 | 2021-12-30 |
| Decision Date | 2022-10-11 |