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510(k) Data Aggregation

    K Number
    K210857
    Device Name
    Personal Lubricant
    Manufacturer
    Shenzhen Huanqiu Xuebao Technology Co., Ltd.
    Date Cleared
    2021-09-24

    (185 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K203257
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Personal Lubricant is a water based 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

    Personal Lubricant is a non-sterile, water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, glycerol, hydroxyethyl cellulose, potassium sorbate, methylparaben, carbomer and triethanolamine. Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 300 mL polyethylene terephthalate bottles.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for a Personal Lubricant, not an AI/ML medical device. Therefore, the information requested in your prompt (acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document.

    The document discusses the substantial equivalence of the Personal Lubricant to a predicate device based on:

    • Indications for Use: Same as predicate.
    • Technological Characteristics: Similarities and differences in formulation, appearance, odor, viscosity, pH, and osmolality are compared.
    • Non-Clinical Performance Testing:
      • Biocompatibility: Tested according to ISO 10993 standards.
      • Shelf-Life: Demonstrated to maintain specifications for 3 years.
      • Condom Compatibility: Tested according to ASTM D7661-10(R) 2017 for compatibility with natural rubber latex and polyisoprene condoms, and incompatibility with polyurethane condoms.

    The document does not describe an AI/ML device or its performance criteria.

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