K173847 is an FDA 510(k) clearance for the Disposable Ultra Reinforced Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Xiantao Rayxin Medical Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on January 16, 2019, 393 days after receiving the submission on December 19, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K173847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2017 |
| Decision Date | January 16, 2019 |
| Days to Decision | 393 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 |