Cleared Traditional

K170762 - Cardinal Health Non-Reinforced Surgical Gown (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170762 · Cardinal Health200, LLC · General Hospital
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K170762.
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K251860 · Copioumed International, Inc. · Feb 2026
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K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026
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