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510(k) Data Aggregation

    K Number
    K163674
    Device Name
    Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
    Manufacturer
    NEO COSMETIQUE
    Date Cleared
    2017-09-22

    (269 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K151884
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.

    Device Description

    Exsens Personal Lubricants are non-sterile, water-based personal lubricants that provide personal lubrication during intimate sexual activity. They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor), Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The product is packaged in a 70ml polyethylene white tube with a flip-top cap and protective sleeve. It is for over-the-counter (OTC) use.

    AI/ML Overview

    The document describes the acceptance criteria and performance data for Exsens Personal Lubricants. This information is presented in the context of a 510(k) premarket notification to the FDA, where the device is compared to a predicate device (K-Y Marilyn Pleasure Gel, K151884) to demonstrate substantial equivalence.

    Here's an organized breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance CriteriaReported Device Performance (Exsens Personal Lubricant)
    AppearanceClear gelClear gel (Implicitly met as it's a characteristic, not a pass/fail test)
    OdorNeutral, mint, candy apple, raspberryNeutral, mint, candy apple, raspberry (Implicitly met based on product description)
    pH5.0 - 6.0Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary")
    Viscosity7000 - 12,000 mPaWithin specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary")
    Density1.14Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary")
    Osmolality600 - 700 mOsmol/kgWithin specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary")
    Antimicrobial EffectivenessMeets acceptance criteria for Category 2 productsMet (Explicitly stated "Meets acceptance criteria for Category 2 products")
    Total Microbial Count
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