Cleared Traditional

VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E (K023754) - FDA 510(k) Clearance

Class I General Hospital device.

K023754 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Mar 2003
Decision
139d
Days
Class 1
Risk

K023754 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Arista Latindo Industrial Ltd. P.T (Jakarta, ID). The FDA issued a Cleared decision on March 25, 2003 after a review of 139 days - within the typical 510(k) review window.

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 Arista Latindo Industrial Ltd. P.T devices

Submission Details

510(k) Number K023754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2002
Decision Date March 25, 2003
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
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 K023754.
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
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