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510(k) Data Aggregation

    K Number
    K143177
    Device Name
    KleenGel Dispenser
    Manufacturer
    KleenGel, LLC
    Date Cleared
    2015-09-14

    (314 days)

    Product Code
    KYX, KMJ
    Regulation Number
    880.6430
    Why did this record match?
    Applicant Name (Manufacturer) :

    KleenGel, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
    Device Description
    The KleenGel Dispenser is a patented automatic dispenser designed to efficiently and hygienically dispense lubricating gel for use by health care providers when performing pelvic and rectal exams or other procedures requiring the use of lubricating gel. The KleenGel Dispenser has an Infrared Sensor for automatic dispensing of lubricating gel onto the providers fingers or on a medical instrument. The unit is designed to be placed on a counter top so it's easily accessible to healthcare providers in exam rooms. The device is battery operated, using four (4) AA (1.5V) batteries. Device also has an optional AC adapter. Sterile Lubricating Gel, (sold separately) is packaged in a 14 oz pre-filled disposable cartridge. Gel is dispensed in 3 volume selections, 1ml, 2ml or 3ml.
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