Cleared Traditional

K160339 - Cardinal Health Isolation Gown

K160339 is an FDA 510(k) clearance for Cardinal Health Isolation Gown, manufactured by Cardinal Health200, LLC. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K160339

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
Combination Product No
PCCP Authorized No
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.

FYC Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K160339.
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
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
K160361 · Primed Medical Products, Inc. · Nov 2016
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
KENTRON'S ISOLATION GOWN
K971917 · Kentron Health Care, Inc. · Sep 1997
IMPERVIOUS ISOLATION GOWN
K972410 · Kentron Health Care, Inc. · Sep 1997