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    K Number
    K111589
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
    Manufacturer
    DERMA CARE PLUS PRODUCTS, LLC
    Date Cleared
    2011-08-23

    (77 days)

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

    DERMA CARE PLUS PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A single use, disposable, powder-free examination glove, intended for medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner.
    Device Description
    White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.
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