Cleared Traditional

K052568 - ESTEEM STRETCHY VINYL GLOVE WITH COATING

K052568 is an FDA 510(k) clearance for ESTEEM STRETCHY VINYL GLOVE WITH COATING, manufactured by Cardinalhealth. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K052568

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Intertek Testing Services
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 372
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K052568.
GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102089 · Grand Work Plastic Products Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102094 · Grand Work Plastic Products Co., Ltd. · Oct 2010
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · Grand Work Plastic Products Co., Ltd. · Jul 2006
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K051148 · Zibo Sinocare Plastic Products Co., Ltd. · Jun 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051154 · Hebei Manful Import & Export Co., Ltd. · Jun 2005

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.