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510(k) Data Aggregation

    K Number
    K160211
    Device Name
    Wet Original Personal Lubricant
    Manufacturer
    TRIGG LABORATORIES D/B/A WET INTERNATIONAL
    Date Cleared
    2016-04-27

    (90 days)

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

    TRIGG LABORATORIES D/B/A WET INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigg Laboratories WET ORIGINAL® 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, polyisoprene, and polyurethane condoms.
    Device Description
    The WET ORIGINAL® Personal Lubricant is a non-sterile device. It is a water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, gel-like, liquid and odorless, aqueous-based. The proposed device contains a blend of ingredients similar to 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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