K210510 is an FDA 510(k) clearance for the Disposable Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Shandong Zhushi Pharmaceutical Group Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on August 12, 2021, 171 days after receiving the submission on February 22, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2021 |
| Decision Date | August 12, 2021 |
| Days to Decision | 171 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 |