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510(k) Data Aggregation

    K Number
    K983612
    Device Name
    POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
    Manufacturer
    SHANGHAI JIATAI PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    1998-11-05

    (22 days)

    Product Code
    LYZ
    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 purpooses that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Jiatai Synthetic Vinyl Exam Gloves, Powder-Free

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification letter from the FDA regarding a submission for "Powder-Free Non-sterile Vinyl Examination Gloves." This letter primarily addresses the substantial equivalence determination of the device and regulatory guidelines, rather than detailed performance study results.

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