Cleared Traditional

K031944 - VINYL EXAMINATION GLOVES

K031944 is an FDA 510(k) clearance for VINYL EXAMINATION GLOVES, manufactured by Arista Latindo Industrial Ltd. P.T. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K031944 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Sep 2003
Decision
91d
Days
Class 1
Risk

K031944 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Arista Latindo Industrial Ltd. P.T (Jakarta, ID). The FDA issued a Cleared decision on September 23, 2003 after a review of 91 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 - K031944

510(k) Number K031944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2003
Decision Date September 23, 2003
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 705
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K031944.
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K033887 · Yty Industry (Manjung) Sdn Bhd · Mar 2004
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
K033683 · Smart Glove Corp. Sdn Bhd · Jan 2004
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024 · Shen Wei (Usa), Inc. · Oct 2003
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
K031625 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2003
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
K031768 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
K031591 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2003