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510(k) Data Aggregation

    K Number
    K032124
    Device Name
    DUREX PLAY LUBRICANT
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2004-01-16

    (190 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K955648,K935299
    Why did this record match?
    Device Name :

    DUREX PLAY LUBRICANT

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

    Durex Play™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

    Device Description

    Durex Play™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification summary for Durex Play™ Personal Lubricant and the FDA's clearance letter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance data for the device itself.

    Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a study proving the device meets acceptance criteria.

    The information present in the document pertains to:

    • Device Description: Durex Play™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
    • Intended Use: As a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
    • Predicate Devices: K-Y Jelly Personal Lubricant (K955648) and AstroGlide (K935299).
    • Substantial Equivalence: Durex Play™ is substantially equivalent to the predicate devices in intended use and similar in composition. All products are marketed as personal lubricants, safe to use with condoms, water soluble, and sold Over-the-Counter.

    In summary, this document describes a regulatory filing based on substantial equivalence, not a clinical or performance study with the detailed aspects requested in the prompt.

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