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510(k) Data Aggregation

    K Number
    K171044
    Device Name
    Climax Personal Lubricant
    Manufacturer
    WSM Investment LLC, dba Topco Sales
    Date Cleared
    2017-11-21

    (228 days)

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

    WSM Investment LLC, dba Topco Sales

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Climax 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 compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    Climax Personal Lubricant is a non-sterile, water soluble, viscous liquid which is intended to be used as a personal lubricant. The ingredients are Purified Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Diazolidinyl Urea, Methylparaben, Propylparaben. The product specifications include appearance, color, odor, pH, viscosity, specific gravity, osmolality, total aerobic microbial count per USP <61>, total yeast and mold count per USP <61>, absence of pathogenic organisms per USP <62>, and antimicrobial effectiveness per USP <51>. Climax Personal Lubricant is packaged in 5 fl. oz, and 6.5 fl. oz. bottles.
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