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510(k) Data Aggregation

    K Number
    K152168
    Device Name
    Love Liquid Personal Lubricant
    Date Cleared
    2016-02-05

    (185 days)

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

    The Kama Sutra Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Love Liquid® 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 compatible with natural rubber latex and Polyisoprene condoms. It is not compatible with polyurethane condoms.
    Device Description
    The Love Liquid® Personal Lubricant is a non-sterile; water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, liquid and odorless, aqueousbased. The proposed device contains a blend of ingredients found in the predicate device. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The device formula is neither a contraceptive nor a spermicide.
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