Cleared Traditional

K242844 - Medline Level 4 Surgical Gown with Breathable Sleeves

K242844 is an FDA 510(k) clearance for Medline Level 4 Surgical Gown with Brea..., manufactured by Medline Industries, LP. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K242844 · Medline Industries, LP · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
159d
Days
Class 2
Risk

K242844 is an FDA 510(k) clearance for the Medline Level 4 Surgical Gown with Breathable Sleeves. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on February 26, 2025 after a review of 159 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, LP devices

FDA 510(k) Submission Details - K242844

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 211
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K242844.
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
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K242937 · Dae Myung Chemical Co., Ltd. (Vietnam) · May 2025
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · Stryker Instruments · Oct 2024
ProPel SG3™ Surgical Gown
K241214 · Standard Textile Co., Inc. · Sep 2024
GCI Surgical Gown
K233571 · George Courey, Inc. · Aug 2024