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510(k) Data Aggregation

    K Number
    K223519
    Device Name
    Carex Hybrid Personal Lubricant
    Manufacturer
    Karex Industries Sdn. Bhd.
    Date Cleared
    2023-08-11

    (261 days)

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

    Carex Hybrid Personal Lubricant is a personal lubricant. for penile 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

    Not Found

    AI/ML Overview

    This document is not about an AI/ML device but rather a 510(k) clearance for a personal lubricant. It does not contain information on acceptance criteria for an AI device, performance studies, sample sizes, expert ground truth, or MRMC studies. Therefore, I cannot fulfill your request based on the provided text.

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