K230610 is an FDA 510(k) clearance for the Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series). This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Dongguan Shin YI Healthcare Products Factory (Dong Guan, CN). The FDA issued a Cleared decision on August 23, 2023, 170 days after receiving the submission on March 6, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K230610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2023 |
| Decision Date | August 23, 2023 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |