Cleared Traditional

K160411 - Cardinal Health Vinyl Powder-Free Exam ...

K160411 is an FDA 510(k) clearance for Cardinal Health Vinyl Powder-Free Exam ..., manufactured by Cardinal Health, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K160411 · Cardinal Health, Inc. · General Hospital
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Jul 2016
Decision
160d
Days
Class 1
Risk

K160411 is an FDA 510(k) clearance for the Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Cardinal Health, Inc. (Waukegan, US). The FDA issued a Cleared decision on July 25, 2016 after a review of 160 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Health, Inc. devices

FDA 510(k) Submission Details - K160411

510(k) Number K160411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date July 25, 2016
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 93
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K160411.
Powder-free Clear Vinyl Patient Examination Gloves
K173078 · Yongsheng Medical Products Co., Ltd. · Mar 2018
Vinyl Patient Examination Glove (Yellow)
K173580 · Nature Medical Products Co., Ltd. · Feb 2018
Vinyl Patient Examination Glove (Yellow)
K173561 · Yurun Glove Co., Ltd. · Feb 2018
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005