K212718 is an FDA 510(k) clearance for the Surgical gowns. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Xiantao Dingcheng Non-Woven Product Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on January 12, 2022, 138 days after receiving the submission on August 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2021 |
| Decision Date | January 12, 2022 |
| Days to Decision | 138 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 |