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510(k) Data Aggregation

    K Number
    K992165
    Device Name
    HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    1999-08-25

    (58 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

    A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

    Device Description

    Powder-free Latex Examination Glove

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves a device meets them. The document is a 510(k) clearance letter from the FDA for "Powder-free Latex Examination Gloves," indicating that the device is substantially equivalent to a legally marketed predicate device.

    The information concerns regulatory approval for a medical device (latex examination gloves) and does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. These are typically found in the 510(k) submission itself, not in the clearance letter.

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