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510(k) Data Aggregation

    K Number
    K203257
    Device Name
    LUBi Water Based Personal Lubricant
    Date Cleared
    2020-12-23

    (49 days)

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

    Boya Biotechnology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LUBi 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    LUBi Water Based Personal Lubricant is a clear, colorless, moderate sweet perfume and viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile 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 sold as an over-the-counter (OTC) product in an 8.54 fl. oz. / 250 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of water (aqua), glycerin, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, disodium ethylenediaminetetraacetic acid (EDTA).
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