K214108 is an FDA 510(k) clearance for the Medline Orbis Chemo Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on May 6, 2022, 128 days after receiving the submission on December 29, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K214108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2021 |
| Decision Date | May 06, 2022 |
| Days to Decision | 128 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 |