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510(k) Data Aggregation

    K Number
    K210857
    Device Name
    Personal Lubricant
    Date Cleared
    2021-09-24

    (185 days)

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

    Shenzhen Huanqiu Xuebao Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Personal Lubricant is a water based 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
    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, glycerol, hydroxyethyl cellulose, potassium sorbate, methylparaben, carbomer and triethanolamine. Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 300 mL polyethylene terephthalate bottles.
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