Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K240081
    Device Name
    Human Lubricant
    Manufacturer
    Jiangxi Wulinxiang Biological Technology Co., Ltd.
    Date Cleared
    2024-08-16

    (218 days)

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

    Jiangxi Wulinxiang Biological Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WLX & Bio Human Lubricant is a 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 product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    WLX & Bio Human Lubricant is a non-sterile, water-based, clear gel personal lubricant. It is a Class II medical device classified under 21 CFR 884.5300 (condom) and product code NUC (lubricant, personal). It contains Water, Glycerin, Propylene Glycol, Carbomer, Hydroxyethylcellulose, Triethanolamine, and Phenoxyethanol. The lubricant is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The lubricant is packaged in polyethylene (PE) bottles of 100 mL capacity (Model -WLX100).
    Ask a Question

    Page 1 of 1