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510(k) Data Aggregation

    K Number
    K181078
    Device Name
    The Sex Gel
    Manufacturer
    Necessaire, Inc.
    Date Cleared
    2018-09-10

    (139 days)

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

    Necessaire, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sex Gel 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 latex, polyisoprene, and polyurethane condoms.
    Device Description
    The Sex Gel is a non-sterile, water-based, over-the-counter personal lubricant, formulated to be a clear liquid. The device contains a blend of ingredients similar to ingredients found in the predicate device. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, or polyurethane condoms during intimate sexual activity. The device formula is neither a contraceptive nor a spermicide. The product is packaged in (50 ml / 1.7 oz) bottles made from high density polypropylene (POLY WHITE P 8555). The bottle is fitted with a pump for dispensing lubricant made of polypropylene, butyl, and steel. Each bottle is packaged in a paperboard carton, which constitutes the device's individual carton.
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