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510(k) Data Aggregation

    K Number
    K162569
    Device Name
    YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
    Date Cleared
    2017-06-09

    (267 days)

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

    BIOTECH LUBRICANTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms. A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    YES® oil-based Personal Lubricant: This non-sterile and oil-based personal lubricant consists primarily of Sunflower oil and Shea butter, and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is a cream-colored thick paste that melts at body temperature. The product is packaged in a high density polyethylene (HDPE) tube with a flip-top cap. YES® water-based Personal Lubricant: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator. YES® Vaginal Moisturizer: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.
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