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510(k) Data Aggregation

    K Number
    K192982
    Device Name
    KY Grosz UltraGel
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2020-04-14

    (172 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K183302
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is intended for penile, vaginal and/or anal application 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

    KY Grosz UltraGel is a personal lubricant that is non-sterile, water-based, 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, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Benzoic acid, Sodium Saccharin, and Sodium Hydroxide. KY Grosz UltraGel is packaged in 1.5 fl. oz. (44 mL) or 4.5 fl. oz. (133 mL) bottles composed of high density polyethylene (HDPE), sealed and fitted with a polypropylene (PP) cap. The individual bottles are packaged in an outer cardboard carton. KY Grosz UltraGel is a personal lubricant for over-the-counter (OTC) use.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the KY Grosz UltraGel, structured to answer your specific questions.

    1. A table of acceptance criteria and the reported device performance

    PropertyAcceptance Criteria (Specification)Reported Device Performance
    Physical/Chemical Properties
    AppearanceColorless to slightly yellow, clear to translucent liquid"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this, though no direct measured value is given in summary)
    OdorNo objectionable odor"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
    Viscosity100-950 cPs"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
    Osmolality780-1180 mOsm/kg"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
    pH3.5 - 4.5"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
    Microbiological Purity
    Total Yeast and Mold Count (TYMC)
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