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510(k) Data Aggregation

    K Number
    K124044
    Device Name
    ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
    Manufacturer
    SEVEN OAKS RANCH, INC.
    Date Cleared
    2013-08-30

    (242 days)

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

    SEVEN OAKS RANCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are personal lubricants, 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. This product is not compatible with polyurethane condoms.
    Device Description
    Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are non-sterile, aloe-based vaginal lubricants designed to supplement the body's own natural lubrication fluids, and to enhance the ease and comfort of intimate sexual activity. Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are specifically formulated with 95% organic aloe. The remaining five percent of ingredients are in all cases food grade and in many cases certified organic. This device is not a contraceptive or spermicide, nor does it contain any such component. All ingredients in Aloe Cadabra Flavored/Scented Lubricants are GRAS (Generally Recognized as Safe by FDA). The specifications for the Aloe Cadabra Lubricants include appearance, odor, pH, viscosity, osmolality, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms (straphylococcus aureus, pseudomonas aeruginosa, escheria coli, salmonella, bile tolerant gram negative bacteria, c. albicans and clostridia). The product is bottled in an HDPE opaque white plastic bottle with a white flip top cap. The bottle is packaged into a carton for sale to consumers. The product comes in five varieties of scents and flavors including Natural Aloe, Pina Colada, Tahitian Vanilla, French Lavender, and Peppermint.
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