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510(k) Data Aggregation

    K Number
    K180923
    Device Name
    Personal Lubricating Jelly
    Manufacturer
    Perrigo New York, Inc.
    Date Cleared
    2018-07-09

    (91 days)

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

    Perrigo New York, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is 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 device is compatible with natural rubber latex condoms and not compatible with polyurethane and polyisoprene condoms.
    Device Description
    Personal Lubricating Jelly is a water-based personal lubricant containing ingredients that are commonly used in vaginal lubrication devices, including water, glycerin, hydroxyethylcellulose, chlorohexidine glucono delta lactone, methylparaben, and sodium hydroxide. It is provided non-sterile.
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