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510(k) Data Aggregation

    K Number
    K231740
    Device Name
    MemorialTM Gloves
    Manufacturer
    US Glove Supply
    Date Cleared
    2023-07-04

    (20 days)

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

    US Glove Supply

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are Blue, Polymer coated, Nonsterile, Powder Free, Ambidextrous Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. These are made up of 100% synthetic Nitrile Butadiene Latex. Its surface finish is finger textured with beaded cuff.
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