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510(k) Data Aggregation

    K Number
    K993287
    Device Name
    POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    Manufacturer
    PAN-CENTURY RUBBER PRODUCTS SDN. BHD.
    Date Cleared
    1999-10-29

    (28 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 patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    POWDER FREE ( SILICON COATED ) LATEX EXAMINATION GLOVES. WITH PROTEIN LABELING CLAIM (50 micrognam or less

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for "Powder Free (Silicon Coated) Latex Examination Gloves with Protein Labelling Claim, 50 Micrograms or Less." This letter is an administrative notice of substantial equivalence determination and does not contain information about acceptance criteria or a study proving that a device meets those criteria.

    Therefore, I cannot answer your request based on the provided text. The document does not describe:

    • Acceptance criteria for a device's performance.
    • A study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • MRMC studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used or how it was established.
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