Cleared Traditional

K160339 - Cardinal Health Isolation Gown

K160339 is the FDA 510(k) clearance for Cardinal Health Isolation Gown by Cardinal Health200, LLC. It is a Class 2 General Hospital device (product code FYC) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K160339 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
171d
Days
Class 2
Risk

K160339 is an FDA 510(k) clearance for the Cardinal Health Isolation Gown. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 28, 2016 after a review of 171 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 Cardinal Health200, LLC devices

Submission Details

510(k) Number K160339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date July 28, 2016
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 31
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K160339.
AMD Ritmed AssureWear VersaGown
K190306 · Amd Medicom, Inc. · Jan 2020
SURGICAL ISOLATION GOWN
K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 2018
Medline Non-Surgical Isolation Gown-
K160471 · Medline Industries, Inc. · Jan 2017
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
CONTROL COVER GOWN
K840229 · Kimberly-Clark Corp. · Mar 1984
BARRIER PLUS SURGEON GOWNS
K801162 · American Hospital Supply Corp. · May 1980