Cleared Traditional

VINYL POWDER-FREE EXAMINATION GLOVES (K946021) - FDA 510(k) Clearance

Class I General Hospital device.

K946021 · Wilson Glove Products Co., Ltd. · General Hospital
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Jun 1995
Decision
196d
Days
Class 1
Risk

K946021 is an FDA 510(k) clearance for the VINYL POWDER-FREE EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Wilson Glove Products Co., Ltd. (Diamond Bar, US). The FDA issued a Cleared decision on June 23, 1995 after a review of 196 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 Wilson Glove Products Co., Ltd. devices

Submission Details

510(k) Number K946021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date June 23, 1995
Days to Decision 196 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 129d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

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 84
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K946021.
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
K962069 · Medline Industries, Inc. · Aug 1996
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · Baxter Healthcare Corp · Jul 1995
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
K944873 · Baxter Healthcare Corp · Mar 1995
TRU-TOUCH MEDICAL GLOVES
K944183 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
POWDER FREE MEDICAL GLOVE
K944182 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1994