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    K Number
    K032010
    Device Name
    GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
    Manufacturer
    PT. WRP BUANA MULTICORPORA
    Date Cleared
    2003-08-19

    (50 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Nitrile Examination Gloves, Blue, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information for the device, based on the provided text:

    Device: Powder Free Nitrile Examination Gloves, Blue, Non-Sterile

    1. Table of Acceptance Criteria and Reported Device Performance:

    CHARACTERISTICSSTANDARDSDEVICE PERFORMANCE
    DimensionsD 6319 - 00ae3Meets
    Physical PropertiesD 6319 - 00ae3Meets
    Freedom from PinholesD 6319 - 00ae3
    FDA 21 CFR 800.20
    FDA 1000 ml Water Leak TestMeets
    Powder Free ResidueD 6124 - 01Meets (
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