K213832 is an FDA 510(k) clearance for the AAMI3 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 May 16, 2022, 158 days after receiving the submission on December 9, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K213832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2021 |
| Decision Date | May 16, 2022 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |