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510(k) Data Aggregation

    K Number
    K030273
    Device Name
    GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
    Manufacturer
    PT. WRP BUANA MULTICORPORA
    Date Cleared
    2003-03-26

    (58 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 :

    GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE

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

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

    AI/ML Overview

    The provided document describes the acceptance criteria and performance of PT. WRP Buana Multicorpora's Latex Examination Gloves, Powdered, Blue, Non-Sterile.

    Here's an analysis based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    CHARACTERISTICSSTANDARDS (Acceptance Criteria)DEVICE PERFORMANCE
    DimensionsD 3578 – 01ae2Meets
    Physical PropertiesD 3578 - 01ae2Meets
    Freedom from PinholesD 3578 - 01ae2, FDA 21 CFR 800.20Meets
    Powder AmountD 3578 - 01ae2, D 6124 - 01
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