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510(k) Data Aggregation

    K Number
    K202017
    Device Name
    Passion Natural Water Based Lubricant
    Manufacturer
    Date Cleared
    2021-01-08

    (171 days)

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

    XR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Passion Natural Water Based 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 polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
    Device Description
    The Passion Natural Water Based Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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 polyisoprene condoms, and is not compatible with natural rubber latex and polyurethane condoms. Its formulation consists of purified water, propanediol, xanthan gum, methocel, sodium benzoate, potassium sorbate, citric acid, and hydroxyethylcellulose. Passion Natural Water Based Lubricant is packaged in 4 oz polyethylene terephthalate bottles with a cap. Passion Natural Water Based Lubricant is a personal lubricant for over-the-counter (OTC) use.
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