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510(k) Data Aggregation

    K Number
    K182100
    Device Name
    Smile Makers Personal Lubricant
    Date Cleared
    2019-04-25

    (265 days)

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

    LFBeauty (Thailand) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Smile Makers Personal Lubricants are water-based personal lubricants for 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Smile Makers personal lubricants are water-based personal lubricants. There are three formulations, Generous Gel, Stay Silky Serum, and Little Light Liquid, that contain the same ingredients, and only differ in amounts of specific ingredients. Ingredients of the lubricants include the following: water (aqua), glycerin, propylene glycol, methyl propanediol, carbomer, sodium benzoate, sodium hydroxide, and dipotassium glycyprizate. They are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms. They are provided non-sterile. The product is packaged in 30 ml transparent plastic bottles made of acrylonitrile styrene and polyethylene terephthalate. The bottle contains a pump dispenser made of polypropylene and the cap is made of an aluminum coated low density polyethylene. It is for over-the-counter use.
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