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510(k) Data Aggregation

    K Number
    K150480
    Device Name
    JO H20 Water Based Personal Lubricant
    Manufacturer
    UNITED CONSORTIUM INC.
    Date Cleared
    2015-07-08

    (134 days)

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

    UNITED CONSORTIUM INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO H2O Personal Lubricant is a water-based personal lubricant, for penile application, intended to lubricate and moisturize, 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. JO H2O Water Based 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
    JO H2O Water Based Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane, and polyisoprene. The device is a non-sterile lubricant, for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene (PET) bottles with Polypropylene caps. The individual bottles are sealed using an induction seal constructed of aluminized mylar. There is a 16 fl. Oz./480 mL bottle with a different configuration consisting of a clear Polyethylene (PET) bottle with a Polypropylene lotion pump. This bottle is fitted with a shrink band.
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