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510(k) Data Aggregation

    K Number
    K211088
    Device Name
    Grosz Play Feel
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2021-07-09

    (88 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K183302
    Why did this record match?
    Device Name :

    Grosz Play Feel

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Grosz Play Feel 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. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.

    Device Description

    Grosz Play Feel 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, Propylene Glycol, Xanthan Gum, Carbomer, Benzoic Acid, and Sodium Hydroxide. Grosz Play feel is packaged in 50 mL bottles composed of High Density Polyethylene (HDPE) and fitted with a Polypropylene (PP) cap. The bottle is packaged in an outer cardboard carton. Grosz Play Feel is a personal lubricant for over-the-counter (OTC) use.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Grosz Play Feel" personal lubricant. This document details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.

    Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Grosz Play Feel personal lubricant are primarily derived from its device specifications and performance testing. The reported device performance is indicated by the results of these tests.

    PropertyAcceptance CriteriaReported Device Performance
    Device Specifications (Table 1)(Implied to meet these specifications as per the submission)
    AppearanceViscous, clear gelViscous, clear gel
    OdorOdorlessOdorless
    Viscosity3,400 - 10,000 cPsWithin the range of 3,400 - 10,000 cPs
    pH3.5 - 4.5Within the range of 3.5 - 4.5
    Osmolality663 - 1,063 mOsm/kgWithin the range of 663 - 1,063 mOsm/kg
    Total Yeast and Mold Count (TYMC)
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