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510(k) Data Aggregation

    K Number
    K212104
    Device Name
    Water-soluble Personal Lubricant
    Date Cleared
    2021-11-18

    (135 days)

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

    Foshan PingChuang Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Water-soluble Personal Lubricant 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
    Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, and sodium polyacrylate. Water-soluble Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 250 mL polyethylene terephthalate bottles.
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