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510(k) Data Aggregation

    K Number
    K112289
    Device Name
    DISPOSABLE THERMOMETER COVERS AND SHEATHS
    Manufacturer
    KANG ZE INDUSTRIAL CO. LIMITED
    Date Cleared
    2011-12-16

    (129 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    KANG ZE INDUSTRIAL CO. LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
    Device Description
    The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are used for either oral or rectal measurements for digital or mercury thermometers. The products and packaging are non-sterile and are not made with natural rubber latex. The size may vary to accommodate differences in digital and mercury thermometers. The inner packing material is paper, while the outer packing material is carton. Each outer packing contains 100 pieces of covers and sheaths.
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