Cleared Traditional

K934536 - VINYL EXAMINATION GLOVES (NON STERILE)

K934536 is an FDA 510(k) clearance for VINYL EXAMINATION GLOVES (NON STERILE), 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 276-day FDA review.

K934536 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Jun 1994
Decision
276d
Days
Class 1
Risk

K934536 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVES (NON STERILE). 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 June 23, 1994 after a review of 276 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 Arista Latindo Industrial Ltd. P.T devices

FDA 510(k) Submission Details - K934536

510(k) Number K934536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1993
Decision Date June 23, 1994
Days to Decision 276 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
147d slower than avg
Panel avg: 129d · This submission: 276d
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 K934536.
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
SYNTHETIC MEDICAL GLOVES
K944184 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1994
SENSICARE POWDER FREE MEDICAL GLOVE
K925244 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
DERMACARE SYNTHETIC MEDICAL GLOVE
K914763 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SENSICARE SYNTHETIC MEDICAL GLOVES
K915478 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992