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    K Number
    K051987
    Device Name
    FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
    Manufacturer
    PT. MANDIRI INTI BUANA
    Date Cleared
    2005-10-06

    (76 days)

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

    FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

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

    Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner

    Device Description

    The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

    AI/ML Overview

    The document describes the Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile, manufactured by PT Mandiri Inti Buana. The device is a disposable glove intended for medical purposes to prevent contamination between patient and examiner.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. A table of acceptance criteria and the reported device performance

    CHARACTERISTICSSTANDARDSACCEPTANCE CRITERIA (Implied by "Meets" or specified values)DEVICE PERFORMANCE
    DimensionD 3587 -01 ae²Conformance to ASTM D 3587 -01 ae²Meets (Conforms to ASTM D 3587 -01 ae²)
    Physical PropertiesD 3587 -01 ae²Conformance to ASTM D 3587 -01 ae²Meets (Conforms to ASTM D 3587 -01 ae²)
    Freedom from PinholesD 3587 -01 ae² & FDA 21 CFR 800.20Conformance to ASTM D 3587 -01 ae² & FDA 21 CFR 800.20Meets (Conforms to ASTM D 3587 -01 ae² & FDA test)
    Powder Free ResidueD 3587 -01 ae² & D6124 - 01
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