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510(k) Data Aggregation

    K Number
    K193032
    Device Name
    KY Grosz Liquid
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2020-04-20

    (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 Liquid is a 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, PEG-400, Propylene glycol, Xanthan Gum, Carbomer, Benzoic acid, Sodium saccharin, and Sodium hydroxide. KY Grosz Liquid may be 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 Liquid is a personal lubricant for over-the-counter (OTC) use.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the KY Grosz Liquid, a personal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness in comparison to a predicate device, KY Banksy Aloe.

    Here's the breakdown of the acceptance criteria and study information:

    Acceptance Criteria and Reported Device Performance

    PropertyAcceptance CriteriaReported Device Performance (KY Grosz Liquid)
    AppearanceClear to translucentClear to translucent
    OdorNo objectionable odorNo objectionable odor
    Viscosity200-1200 cPs(Not explicitly stated if within range, but implied satisfactory)
    Osmolality690-1090 mOsm/kg(Not explicitly stated if within range, but implied satisfactory)
    pH3.5 - 4.5(Not explicitly stated if within range, but implied satisfactory)
    Total Yeast and Mold Count (TYMC)
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