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510(k) Data Aggregation

    K Number
    K123770
    Device Name
    WARMING JELLY PERSONAL LUBRICANT
    Date Cleared
    2013-04-09

    (123 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISCONSIN PHARMACAL CO., LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Warming Jelly Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.
    Device Description
    Warming Jelly Personal Lubricant is a clear, odorless, non-sterile, water-soluble jelly for use as a personal lubricant. The product imparts a mild warming sensation when applied to the genitalia. Warming Jelly Personal Lubricant can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms as defined by ASTM D7661 - 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Warming Jelly Personal Lubricant is not a contraceptive or spermicide.
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