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510(k) Data Aggregation

    K Number
    K251141

    Validate with FDA (Live)

    Device Name
    Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Mercator Medical (Thailand), Ltd.
    Date Cleared
    2025-11-17

    (217 days)

    Product Code
    LZA,LZC,OPJ,QDO
    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

    Powder-Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
    Warning - Not for Use with Carmustine and Thiotepa

    Powder-Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
    Warning - Not for Use with Carmustine and Thiotepa

    Device Description

    Not Found

    AI/ML Overview

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