K192560 is an FDA 510(k) clearance for the Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Shandong Kangli Medical Equipment Technology Co., Ltd. (Zaozhuang, CN). The FDA issued a Cleared decision on May 22, 2020, 248 days after receiving the submission on September 17, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K192560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2019 |
| Decision Date | May 22, 2020 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |