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510(k) Data Aggregation

    K Number
    K211998
    Device Name
    Desnuda Reflect
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2021-11-18

    (143 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K150883
    Why did this record match?
    Device Name :

    Desnuda Reflect

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

    Desnuda Reflect 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

    Desnuda Reflect is a water-based personal lubricant that is non-sterile 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, hydroxyethyl cellulose, xanthan gum, hyaluronic acid, Zemea propanediol, sodium benzoate, potassium sorbate, and DL lactic acid. Desnuda Reflect is packaged in 2 fl. oz high-density polyethylene pump bottles. Desnuda Reflect is a personal lubricant for over-the-counter (OTC) use.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for a medical device called "Desnuda Reflect," a personal lubricant. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical imaging, which is what your query is geared towards.

    Therefore, I cannot provide the detailed information requested in points 1-9 of your prompt, as the document concerns a physical product (personal lubricant) and its testing for safety and effectiveness as a lubricant, not a digital AI medical device.

    The document discusses various performance tests relevant to a personal lubricant, such as:

    • Biocompatibility testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
    • Condom Compatibility testing: Adherence to ASTM D7661-18 for natural rubber latex and polyisoprene condoms.
    • Shelf-life testing: Accelerated aging study to confirm maintenance of specifications over one year.
    • Device Specifications (Table 1): Appearance, color, odor, viscosity, osmolality, pH, microbial counts (TAMC, TYMC), absence of specific pathogens, and antimicrobial effectiveness.

    These tests establish the safety and effectiveness of the lubricant but are not related to the acceptance criteria or study design for an AI medical imaging device.

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