K242844
- 510(k) number
- K242844
- Device name
- Medline Level 4 Surgical Gown with Breathable Sleeves
- Applicant
- Medline Industries, LP IL · US
- Product code
- FYA — Gown, Surgical
- Decision date
- 2025-02-26
- Date received
- 2024-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K242844.pdf
Official FDA record: K242844
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.