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510(k) Data Aggregation

    K Number
    K202667
    Device Name
    Personal Lubricant Jelly
    Date Cleared
    2021-05-18

    (246 days)

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

    **Nantong Health **& Beyond Hygienic Products Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Personal Lubricant Jelly 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 condoms. This product is not compatible with polyurethane condoms and polyisoprene condoms.
    Device Description
    Personal Lubricant Jelly is a clear, slightly yellow, water-based personal lubricant that is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. The subject lubricant contains water, hydroxyethylcellulose, glycerin, phenoxyethanol, sodium benzoate, and lactic acid. The subject lubricant is provided in two types of packages: a 2 oz. and 4 oz. polyethylene tube with a screw on top, with sealing film placed over the tube, and a 2.5 oz high density polyethylene bottle with a screw on top. The subject lubricant is a personal lubricant for over the counter (OTC) use.
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