Cleared Traditional

K954153 - ARISTA VINYL EXAMINATION GLOVES

K954153 is an FDA 510(k) clearance for ARISTA VINYL EXAMINATION GLOVES, manufactured by Arista Latindo Industrial Ltd. P.T. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K954153 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Jan 1996
Decision
143d
Days
Class 1
Risk

K954153 is an FDA 510(k) clearance for the ARISTA VINYL EXAMINATION GLOVES. 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 January 26, 1996 after a review of 143 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

FDA 510(k) Submission Details - K954153

510(k) Number K954153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date January 26, 1996
Days to Decision 143 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 129d · This submission: 143d
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 109
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K954153.
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
K991951 · Safeskin Corp. · Jul 1999
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
K992122 · Maxxim Medical · Jul 1999
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