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510(k) Data Aggregation

    K Number
    K974223
    Device Name
    NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
    Date Cleared
    1997-12-18

    (36 days)

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

    DERLIN COMPANY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
    Device Description
    Nitrile Powder Free Patient Examination Gloves
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    K Number
    K964817
    Device Name
    DERLIN
    Date Cleared
    1997-01-24

    (56 days)

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

    DERLIN COMPANY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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