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510(k) Data Aggregation

    K Number
    K031020
    Device Name
    FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
    Manufacturer
    PT. MANDIRI INTI BUANA
    Date Cleared
    2003-05-21

    (51 days)

    Product Code
    LYY
    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

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

    Device Description

    The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

    AI/ML Overview

    This document describes the acceptance criteria and performance of the PT. Mandiri Inti Buana Latex Examination Gloves, Powdered, Non-Sterile.

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance Criteria (Standard)Reported Device Performance
    DimensionsASTM D 3578 - 01a2Meets
    Physical PropertiesASTM D 3578 - 01a2Meets
    Freedom from PinholesASTM D 3578 - 01a2 & FDA 21 CFR 800.20 (1000 ml Water Leak Test)Meets
    Powder AmountASTM D 3578 - 01a2 & ASTM D 6124 - 01
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