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510(k) Data Aggregation

    K Number
    K220273
    Device Name
    Onetouch Non-paraben Lubricant Gel
    Manufacturer
    Thai Nippon Rubber Industry Public Company Limited.
    Date Cleared
    2022-10-21

    (263 days)

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

    Thai Nippon Rubber Industry Public Company Limited.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Onetouch™ Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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
    Onetouch™ Non-paraben Lubricant Gel is a non-sterile, water-based, over-the-counter use personal lubricant that is intended for penile, vaginal and/or anal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Onetouch™ Nonparaben Lubricant Gel is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms. Onetouch™ Non-paraben Lubricant Gel has the following eight flavor and color versions: - 1. Natural Color, No Flavor - 2. Natural Color, Cucumber Flavor - 3. Natural Color, Mixfruit Flavor - Pink Color, Strawberry Flavor 4. - 5. Natural Color, Strawberry Flavor - 6. Natural Color, Vanilla Flavor - 7. Natural Color, Mentha Piperita (Peppermint) Flavor - Natural Color, Aloe Vera Flavor 8. The formulations of all versions consist of purified water, hydroxyethyl cellulose, refined glycerin, propane-1,3-diol, sodium benzoate, and PEG-40 hydrogenated castor oil. Specific versions of the device include flavors or a pink colorant, as shown in the list above. Onetouch™ Non-paraben Lubricant Gel is packaged in 75ml LDPE plastic tubes or 5 ml PE layered aluminum foil sachets. Sachets and tubes are secondarily packaged in cartons.
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