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510(k) Data Aggregation

    K Number
    K251773
    Device Name
    Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
    Manufacturer
    Shenzhen Yongquan Medical Devices Co., Ltd.
    Date Cleared
    2025-09-09

    (91 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K240081
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Water-soluble Personal Lubricant is a water based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

    Device Description

    Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of pure water, glycerin, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, sodium lactate, flavors, ethylenediaminetetraacetic acid, etc. The subject device includes four different flavors of water-soluble personal lubricants: Vitamin E flavor, Caramel flavor, Peach flavor, and Strawberry flavor. This device is not compatible with natural rubber latex, polyisoprene and polyurethane condoms.

    The lubricant is packaged in PE bottles of 100gm.

    AI/ML Overview

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