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510(k) Data Aggregation

    K Number
    K060145
    Device Name
    FDS INTIMATE AND INTIMATE WARMING LUBRICANT
    Manufacturer
    ALBERTO-CULVER USA, INC.
    Date Cleared
    2006-04-14

    (85 days)

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

    ALBERTO-CULVER USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, to enhance condom use and the ease of intimate activity.
    Device Description
    The FDS Intimate Lubricant formula is non-sticky, non-staining, non-greasy and is compatible with latex condoms in laboratory testing. It is a water soluble, clear, high viscosity, gel-like liquid. Because it is water soluble, FDS Intimate Lubricant is easily rinsed off with water. The product can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to the standards as defined by ASTM D 3492. FDS Intimate Warming Lubricant is neither a contraceptive nor a spermicide. The product is packaged in a convenient to use pump bottle. The FDS Intimate Warming Lubricant is a non-sticky, non-staining, non-greasy gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the skin. The product can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to the standards as defined by ASTM D 3492. FDS Intimate Warming Lubricant is neither a contraceptive nor spermicide. It contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients, all of which are listed as "generally recognized as safe".
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