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510(k) Data Aggregation

    K Number
    K190323
    Device Name
    Aloe Glide Lubricant
    Date Cleared
    2019-09-25

    (224 days)

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

    Desert Harvest, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aloe Glide Lubricant 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Aloe Glide Lubricant is a personal lubricant that is non-sterile, waterbased, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, xanthan gum, licorice and marshmallow extract, aloe barbadensis leaf extract, potassium sorbate, citric acid, and natapres. Aloe Glide is packaged in 2, 4, and 8 fl. oz bottles composed of polyethylene terephthalate (PET). Aloe Glide lubricant is a personal lubricant for over-the-counter (OTC) use.
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