Cleared Traditional

K182172 - Medline Level 4 Surgical Gown (Sirus)

K182172 is the FDA 510(k) clearance for Medline Level 4 Surgical Gown (Sirus) by Medline Industries, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 147
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