K213893 is an FDA 510(k) clearance for the Comfort Gown, Safewear Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Xuchang Zhengde Environstar Medical Products Co., Ltd. (Xuchang, CN). The FDA issued a Cleared decision on December 21, 2022, 372 days after receiving the submission on December 14, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K213893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2021 |
| Decision Date | December 21, 2022 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |