K220435 is an FDA 510(k) clearance for the SEJONG Surgical Gown Soft. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Sejong Healthcare Co., Ltd. (Paju –Si, KR). The FDA issued a Cleared decision on February 10, 2023, 361 days after receiving the submission on February 14, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K220435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2022 |
| Decision Date | February 10, 2023 |
| Days to Decision | 361 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 |