Cleared Traditional

K052568 - ESTEEM STRETCHY VINYL GLOVE WITH COATING

K052568 is the FDA 510(k) clearance for ESTEEM STRETCHY VINYL GLOVE WITH COATING by Cardinalhealth. It is a Class 1 General Hospital device (product code LYZ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K052568 · Cardinalhealth · General Hospital
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Nov 2005
Decision
70d
Days
Class 1
Risk

K052568 is an FDA 510(k) clearance for the ESTEEM STRETCHY VINYL GLOVE WITH COATING. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on November 28, 2005 after a review of 70 days - a notably fast clearance 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: 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 Cardinalhealth devices

Submission Details

510(k) Number K052568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2005
Decision Date November 28, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

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 91
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K052568.
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
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDERED VINYL EXAMINATION GLOVES
K033692 · Shen Wei (Usa), Inc. · Jan 2004
POWDER-FREE VINYL EXAMINATION GLOVES
K033693 · Shen Wei (Usa), Inc. · Jan 2004