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510(k) Data Aggregation

    K Number
    K143346
    Device Name
    Powder-Free White Vinyl Patient Examination Gloves
    Manufacturer
    Zibo Changda Plastic Products Company, Limited
    Date Cleared
    2015-07-22

    (243 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K102558
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder-Free White Vinyl Patient 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 White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

    AI/ML Overview

    I am sorry, but the provided text describes a 510(k) premarket notification for "Powder-Free White Vinyl Patient Examination Gloves," seeking substantial equivalence to a predicate device.

    The document does not contain information about a medical device that utilizes AI, machine learning, or complex algorithms requiring extensive testing with test sets, expert ground truth, or multi-reader multi-case studies. It focuses on the physical and performance characteristics of medical gloves, adhering to established ASTM standards and FDA regulations for such devices.

    Therefore, I cannot extract the information required to populate the tables and answer the questions related to acceptance criteria, AI performance studies, expert adjudication, or training data for a complex algorithmic device.

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