Cleared Traditional

K170762 - Cardinal Health Non-Reinforced Surgical Gown

K170762 is an FDA 510(k) clearance for Cardinal Health Non-Reinforced Surgical..., manufactured by Cardinal Health200, LLC. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K170762 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
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Jun 2017
Decision
88d
Days
Class 2
Risk

K170762 is an FDA 510(k) clearance for the Cardinal Health Non-Reinforced Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 9, 2017 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardinal Health200, LLC devices

FDA 510(k) Submission Details - K170762

510(k) Number K170762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2017
Decision Date June 09, 2017
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 219
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K170762.
Surgical gown (AE1001, AE2001, AE3001)
K172987 · Gmax Industries, Inc. · Jul 2018
Medline Prevention CoolZone Gown
K172954 · Medline Industries, Inc. · Jun 2018
RoyalGuard Surgical Gown, i600, Breathable
K172445 · Gri Medical & Electrical Technology Co., Ltd. · Dec 2017
Aero Chrome* Select Breathable Performance Surgical Gowns
K162930 · Halyard Health, Inc. · Apr 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