K203415 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 Yanbian Pacific Textile Co., Ltd. (Longjing, CN). The FDA issued a Cleared decision on May 20, 2021, 182 days after receiving the submission on November 19, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2020 |
| Decision Date | May 20, 2021 |
| Days to Decision | 182 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 |