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510(k) Data Aggregation

    K Number
    K091942

    Validate with FDA (Live)

    Device Name
    POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    ZIBO INTCO MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2009-09-21

    (83 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    12 - 120
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

    Device Description

    Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.

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