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510(k) Data Aggregation

    K Number
    K990270
    Device Name
    LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-02-18

    (21 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

    Laglove™ Brand Latex Examination Glove (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

    Device Description

    Laglove™ Brand Latex Examination Gloves (Powder Free) contains 50mcgm less of total water extractable protein per gram.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a latex examination glove, not a study describing the acceptance criteria and performance of a medical device in the context of an AI/algorithm-based system.

    Therefore, I cannot extract the requested information because the document does not contain:

    • A table of acceptance criteria and reported device performance for an AI/algorithm.
    • Information about sample sizes for test sets, data provenance, or training sets in the context of an AI study.
    • Details regarding expert ground truth establishment, adjudication methods, or MRMC studies.
    • Mention of standalone performance or the type of ground truth used for AI training.

    The document is a regulatory approval for a physical product (gloves) based on substantial equivalence to a predicate device, not on the performance of a diagnostic algorithm or AI system.

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