Cleared Abbreviated

K210688 - AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K210688 · O&M Halyard, Inc. · General Hospital

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Jul 2021

Decision

135d

Days

Class 2

Risk

K210688 is an FDA 510(k) clearance for the AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line.... 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 July 21, 2021 after a review of 135 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	K210688 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 2021
Decision Date	July 21, 2021
Days to Decision	135 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

7d slower than avg

Panel avg: 128d · This submission: 135d

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.