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510(k) Data Aggregation

    K Number
    K033530
    Device Name
    ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    ASIA PACIFIC LATEX SDN BHD
    Date Cleared
    2004-01-28

    (79 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

    The Powder Free Latex Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder Free Latex Examination Gloves

    AI/ML Overview

    This document is a marketing authorization letter from the FDA for a medical device (examination gloves). It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced diagnostic or AI-powered devices. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices, a regulatory pathway under 510(k).

    Therefore, I cannot provide the requested information from this document. The document doesn't describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size for test set or data provenance.
    3. Number of experts or their qualifications for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study or effect size.
    6. Standalone (algorithm only) performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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