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510(k) Data Aggregation

    K Number
    K151647
    Device Name
    Uberlube
    Manufacturer
    Date Cleared
    2015-09-23

    (97 days)

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

    UBERLUBE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Überlube 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Überlube is a clear, colorless, semi-viscous silicone-based personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is normally packaged in glass bottles with pump tops or in foil samples. It may also be packaged in stoppered glass vials or plastic bottles. The specifications for Überlube include appearance, odor, viscosity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
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