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510(k) Data Aggregation

    K Number
    K243107
    Device Name
    Water Solubility Human Body Lubricant
    Manufacturer
    Dongguan Yanxuan Biotechnology Co., Ltd.
    Date Cleared
    2025-05-09

    (221 days)

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

    Dongguan Yanxuan Biotechnology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Water Solubility Human Body 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 Solubility Human Body Lubricant is a clear, colorless, odorless and semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene, and is not compatible with polyurethane condoms. This device is a non-sterile 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 sold as an over-the-counter (OTC) product in 120 mL size provided in clear polyethylene terephthalate (PET) bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of Hyaluronic acid, Lubrajel CG, Lubrajel oil, Panthenol, Trimethyl glycine, Pentanediol, Hydroxyacetophenone, Ethylene glycol, Glycerol, Purified water.
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