Cleared Traditional

Medline Level 4 Surgical Gown with Breathable Sleeves

K242844 · Medline Industries, LP · General Hospital
Feb 2025
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K242844 is an FDA 510(k) clearance for the Medline Level 4 Surgical Gown with Breathable Sleeves, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Medline Industries, LP (Nortfield, 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 review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K242844 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FYA — Gown, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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