Cleared Traditional

K162930 - Aero Chrome* Select Breathable Performance Surgical Gowns

K162930 is an FDA 510(k) clearance for Aero Chrome* Select Breathable Performa..., manufactured by Halyard Health, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K162930 · Halyard Health, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2017
Decision
184d
Days
Class 2
Risk

K162930 is an FDA 510(k) clearance for the Aero Chrome* Select Breathable Performance Surgical Gowns. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Halyard Health, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 21, 2017 after a review of 184 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 Halyard Health, Inc. devices

FDA 510(k) Submission Details - K162930

510(k) Number K162930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2016
Decision Date April 21, 2017
Days to Decision 184 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
55d slower than avg
Panel avg: 129d · This submission: 184d
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 240
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K162930.
Medline Prevention CoolZone Gown
K172954 · Medline Industries, Inc. · Jun 2018
RoyalGuard Surgical Gown, i600, Breathable
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Cardinal Health Non-Reinforced Surgical Gown
K170762 · Cardinal Health200, LLC · Jun 2017
ComfortGuard Surgical Gown, i600, Film Reinforced
K163191 · Gri Medical & Electrical Technology Co., Ltd. · Feb 2017
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
K162442 · Gri Medical & Electrical Technology Co., Ltd. · Dec 2016
Blockade Surgical Gown
K150598 · Medline Industries, Inc. · Apr 2016