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510(k) Data Aggregation

    K Number
    K113639
    Device Name
    C2 MEDICAL GLOVES
    Manufacturer
    AMERCARE, INC.
    Date Cleared
    2012-05-08

    (151 days)

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

    AMERCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free, non-sterile patient examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Patient Examination glove - Disposable- Single use only - Non-sterile - The C2 Powder Free Polyethylene Examination Gloves are made of translucent (clear), . Low Density Polyethylene material and are powder free. The C2 Powder Free Polyethylene Examination Gloves come in five sizes: Small, Medium, Large, X Large and XX Large. The gloves are loose fitting.
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