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510(k) Data Aggregation

    K Number
    K162207
    Device Name
    Restore Moisturizing Vaginal Lubricant
    Manufacturer
    Good Clean Love
    Date Cleared
    2017-05-04

    (272 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K150094
    Why did this record match?
    Device Name :

    Restore Moisturizing Vaginal Lubricant

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

    Good Clean Love BIO-pHRESH 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. It is not compatible with polyurethane condoms.

    Device Description

    Good Clean Love BIO-pHRESH contains water-solvent materials. The primary ingredient (95%) is aloe vera and it includes aromatics of apple. The product is provided in tube container and has a gel consistency. It is supplied with a vaginal applicator. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The product is formulated to match the osmolality and pH found in the human vagina.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter and supporting summary for a personal lubricant called "Good Clean Love - BIO-pHRESH." This document DOES NOT describe a study involving an AI-powered device or a medical imaging device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the information contained within this document.

    The document discusses the substantial equivalence of the lubricant to predicate devices based on:

    • Non-clinical performance testing: Compatibility with condoms (latex and polyisoprene only), antimicrobial effectiveness, appearance, color, odor, texture, pH, specific gravity, viscosity, osmolality, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), and shelf-life.
    • Formulation comparison: Similar primary ingredients (aloe vera), thickeners, and preservatives to predicate devices.
    • Intended use: Moisturizing and lubricating for intimate sexual activity, supplementing natural lubrication, and compatibility with specific condom types.

    The conclusion drawn is that the product is as safe and effective as its predicate devices, supporting a determination of substantial equivalence for marketing.

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