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510(k) Data Aggregation

    K Number
    K180014
    Device Name
    Creme de La Femme Feminine Lubricant
    Date Cleared
    2018-12-21

    (353 days)

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

    Cewal, Inc. dba Premiere Enterprises

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Crème de la Femme Feminine 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, polyurethane, and polyisoprene condoms.
    Device Description
    Crème de la Femme Feminine Lubricant is a non-sterile, mineral oil based personal lubricant designed to supplement the body's own natural lubrication fluids, and to enhance the ease and comfort of intimate sexual activity. The product is provided in a low-density polyethylene tube with a white polypropylene screw on the cap. The device will be supplied with an applicator. Its specifications include appearance, color, odor, pH, viscosity, antimicrobial effectiveness (USP<51>), total aerobic microbial count (USP<61>), total yeast and mold count (USP<62>, and absence of pathogenic organisms (USP<62>). The lubricant is not a spermicide or contraceptive. The device is not compatible with natural rubber latex, polyisoprene or polyurethane condoms.
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