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510(k) Data Aggregation

    K Number
    K220121
    Device Name
    Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
    Manufacturer
    AAMedix Glove Sdn Bhd
    Date Cleared
    2022-04-11

    (83 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAMedix Glove Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free 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.
    Device Description
    The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.
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