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510(k) Data Aggregation

    K Number
    K182089
    Device Name
    Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
    Manufacturer
    Platinum Glove Industries Sdn Bhd
    Date Cleared
    2019-07-30

    (362 days)

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

    Platinum Glove Industries Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
    Device Description
    Powder Free Blue Nitrite Examination Gloves- Tested for Use with Chemotherapy Drugs.
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