K242844 is an FDA 510(k) clearance for the Medline Level 4 Surgical Gown with Breathable Sleeves. 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 February 26, 2025, 159 days after receiving the submission on September 20, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K242844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2024 |
| Decision Date | February 26, 2025 |
| Days to Decision | 159 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 |