Cleared Traditional

ARISTA VINYL EXAMINATION GLOVES (K954153) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 129d · This submission: 143d
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 K954153.
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
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