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510(k) Data Aggregation

    K Number
    K060778
    Device Name
    SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
    Manufacturer
    EVER LIGHT PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2006-04-28

    (37 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K142571
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Synthetic Vinyl Patient Examination Glove-Powder Free

    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 the device meets those criteria. The document is an FDA 510(k) clearance letter for a "Synthetic Vinyl Patient Examination Glove-Powder Free" and details regulatory information, but not performance study results or specific acceptance criteria for the product's performance.

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