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510(k) Data Aggregation

    K Number
    K032647
    Device Name
    ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Date Cleared
    2003-11-07

    (72 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

    The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

    Device Description

    The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Device: Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera (Trade Names: Aloetouch, Multiple or Customer's Trade Name)

    1. Table of Acceptance Criteria and Reported Device Performance

    CHARACTERISTICSSTANDARDSACCEPTANCE CRITERIADEVICE PERFORMANCE
    DimensionsASTM D 3577 - 01aE2Meets ASTM D 3577 - 01aE2Meets (reported as "Meets")
    Physical PropertiesASTM D 3577 - 01aE2Meets ASTM D 3577 - 01aE2Meets (reported as "Meets")
    Freedom from pinholesASTM D 3577 - 01aE2Meets ASTM D 3577 - 01aE2 and FDA 21 CFR 800.20 for water leak test on pinhole AQLMeets (reported as "Meets")
    FDA 21 CFR 800.20
    Powder-FreeASTM D 6124 - 01
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