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510(k) Data Aggregation

    K Number
    K212998
    Device Name
    Powder Free Nitrile Examination Gloves (White, Blue and Black)
    Manufacturer
    Alcatron Gloves Factory
    Date Cleared
    2022-02-19

    (152 days)

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

    Alcatron Gloves Factory

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder free nitrile examination gloves (white, blue and black) 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
    Powder Free Nitrile Examination Gloves (White, Blue and Black)
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    K Number
    K112222
    Device Name
    ALCATRON AND / OR MULTIPLE BRAND
    Manufacturer
    ALCATRON GLOVES FACTORY
    Date Cleared
    2011-10-27

    (86 days)

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

    ALCATRON GLOVES FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Synthetic Vinyl Examination Gloves, powder free is a non-sterile 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
    Synthetic Vinyl Examination Gloves, Powder-Free
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