K221559 is an FDA 510(k) clearance for the Disposable Surgical Gown, Level 4. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stringking (Gardena, US). The FDA issued a Cleared decision on February 23, 2023, 268 days after receiving the submission on May 31, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K221559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2022 |
| Decision Date | February 23, 2023 |
| Days to Decision | 268 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 |