K202447 is an FDA 510(k) clearance for the Medline Orbis Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on April 2, 2021, 219 days after receiving the submission on August 26, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2020 |
| Decision Date | April 02, 2021 |
| Days to Decision | 219 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 |