Cleared Traditional

K182172 - Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)

K182172 is an FDA 510(k) clearance for Medline Level 4 Surgical Gown (Sirus), manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K182172 · Medline Industries, Inc. · General Hospital
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Apr 2019
Decision
257d
Days
Class 2
Risk

K182172 is an FDA 510(k) clearance for the Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on April 24, 2019 after a review of 257 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, Inc. devices

FDA 510(k) Submission Details - K182172

510(k) Number K182172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date April 24, 2019
Days to Decision 257 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
128d slower than avg
Panel avg: 129d · This submission: 257d
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 K182172.
Aero Blue Performance Surgical Gowns
K192362 · O&M Halyard, Inc. · Dec 2019
TotalShield II Surgical Helmet System
K192194 · Zimmer Surgical, Inc. · Oct 2019
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
K190950 · Medline Industries, Inc. · Jul 2019
Disposable Ultra Reinforced Surgical Gown
K173847 · Xiantao Rayxin Medical Products Co., Ltd. · Jan 2019
Surgical gown (AE1001, AE2001, AE3001)
K172987 · Gmax Industries, Inc. · Jul 2018
Medline Prevention CoolZone Gown
K172954 · Medline Industries, Inc. · Jun 2018