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510(k) Data Aggregation

    K Number
    K130667
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
    Date Cleared
    2013-07-24

    (134 days)

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

    PREVENTIVE CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An Examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger, to prevent contamination between the patient and examiner.
    Device Description
    The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject.
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    K Number
    K110102
    Device Name
    POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
    Date Cleared
    2011-05-13

    (120 days)

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

    PREVENTIVE CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled
    Device Description
    Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled
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