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510(k) Data Aggregation

    K Number
    K152918
    Device Name
    Gun Oil, Pink, Gun Oil H2O, Pink Water
    Manufacturer
    EMPOWERED PRODUCTS, INC.
    Date Cleared
    2016-06-02

    (244 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Gun Oil, Pink, Gun Oil H2O, Pink Water

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

    Gun Oil silicone lubricant is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.

    Pink silicone lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.

    Gun Oil H20 water-based is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.

    Pink Water water-based lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.

    Device Description

    Not Found

    AI/ML Overview

    I am unable to answer this question. The provided document is a letter from the FDA regarding a 510(k) premarket notification for personal lubricants (condoms). It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific details requested in the prompt, such as sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from this document.

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