K171535 is an FDA 510(k) clearance for the SURGICAL ISOLATION GOWN. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Jingzhou Haixin Green Cross Medical Products Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on February 15, 2018, 266 days after receiving the submission on May 25, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K171535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2017 |
| Decision Date | February 15, 2018 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |