Cleared Abbreviated

K192362 - Aero Blue Performance Surgical Gowns

K192362 is the FDA 510(k) clearance for Aero Blue Performance Surgical Gowns by O&M Halyard, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K192362 · O&M Halyard, Inc. · General Hospital
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Dec 2019
Decision
105d
Days
Class 2
Risk

K192362 is an FDA 510(k) clearance for the Aero Blue Performance Surgical Gowns. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on December 13, 2019 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all O&M Halyard, Inc. devices

Submission Details

510(k) Number K192362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date December 13, 2019
Days to Decision 105 days
Submission Type Abbreviated
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
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

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 K192362.
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
K192290 · Xuchang Zhengde Environstar Medical Products Co., Ltd. · Apr 2020
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
K193327 · Cardinal Health200, LLC · Mar 2020
AERO CHROME* Breathable Performance Surgical Gowns
K200522 · O&M Halyard, Inc. · Mar 2020
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
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
K182172 · Medline Industries, Inc. · Apr 2019