K214116 is an FDA 510(k) clearance for the AAMI4 Isolation Gown. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Hubei Xinxin Non-Woven Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on October 11, 2022, 285 days after receiving the submission on December 30, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K214116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2021 |
| Decision Date | October 11, 2022 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |