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510(k) Data Aggregation

    K Number
    K191480
    Device Name
    Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
    Manufacturer
    Trigg Laboratories, Inc. D/B/A Wet International
    Date Cleared
    2019-10-11

    (129 days)

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

    Trigg Laboratories, Inc. D/B/A Wet International

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a personal lubricant for penile, anal 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
    The Wet Water Based Personal Lubricant is a non-sterile, water and silicone blend personal lubricant that provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. The Wet Water Based Personal Lubricant is provided in 3 oz.high density polyethylene terephthalate bottle is fitted with dispensing bottle cap with a disc-top. Wet Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
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