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510(k) Data Aggregation

    K Number
    K253983

    Validate with FDA (Live)

    Device Name
    Water-based lubricant
    Manufacturer
    Guangzhou Haoyimai Trading Co., Ltd.
    Date Cleared
    2026-03-06

    (84 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    K240745
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Water-based lubricant is a personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

    Device Description

    Water-based lubricant is a non-sterile, water-based personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

    Its formulation consists of purified water, 1,3-butanediol, propylene glycol, carbomer, glycerin, sodium hyaluronate, hydroxyethyl cellulose, sodium benzoate, sodium polyacrylate, citric acid, menthol, essence, and octyl hydroxamic acid.

    AI/ML Overview

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