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510(k) Data Aggregation

    K Number
    K072197
    Device Name
    POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
    Manufacturer
    METACURE SURGICAL GLOVES SDN BHD
    Date Cleared
    2008-03-12

    (218 days)

    Product Code
    LZC,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 that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves that have been tested for use with chemotherapy drugs are not intended to be used as a chemical barrier.

    Device Description

    Powderfree Blue Latex Examination Gloves – Tested For Use With Chemotherapy Drugs; Powderfree Natural Latex Examination Gloves - Not Tested For Use With Chemotherapy Drugs

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding patient examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot answer your request based on the provided text.

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