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510(k) Data Aggregation

    K Number
    K070760
    Device Name
    POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
    Manufacturer
    DERMA CARE PLUS PRODUCTS LLC
    Date Cleared
    2007-06-07

    (79 days)

    Product Code
    LYY
    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 non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.
    Device Description
    POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE
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