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510(k) Data Aggregation

    K Number
    K042239
    Device Name
    FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
    Manufacturer
    PT. MANDIRI INTI BUANA
    Date Cleared
    2004-12-16

    (120 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    POWDER TREE NITRILE EXAMINATION GLOVES, BLUE NON STERILE is a disposable device and make of Synthetic Is a Gropodosatibits rubber like Characteristics Intended For Medical Purpose that is worn on the Incended roz 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 6319-00a53 and FDA 1000 ml Water Leak Test.

    AI/ML Overview

    The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Blue Examination Gloves, Blue, Non Sterile." This is a medical device and not an AI/ML powered device, so many of the requested fields are not applicable.

    Here's the information extracted from the document:

    1. Table of Acceptance Criteria and Reported Device Performance:

    CHARACTERISTICSSTANDARDSACCEPTANCE CRITERIADEVICE PERFORMANCE
    DimensionD 6319-00aE3Meets D 6319-00aE3Meets
    Physical PropertiesD 6319-00aE3Meets D 6319-00aE3Meets
    Freedom from PinholesD 6319-00aE3, FDA 21 CFR 800.20Meets D 6319-00aE3, FDA 21 CFR 800.20Meets (specifically, FDA 1000 ml Water Leak Test and Pinhole AQL)
    Powder ResidueD 6319-00aE3, D6124 - 01
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