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510(k) Data Aggregation

    K Number
    K984218
    Device Name
    OASIS
    Manufacturer
    GLIMEX CORP.
    Date Cleared
    1998-12-17

    (23 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLIMEX CORP.

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

    The Oasis™ brand condoms are used for contraccption and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted discascs).

    Device Description

    Oasis™ brand Male Natural Rubber Latex Condom, natural and color, silicone lubricated

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a male condom. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory requirements for marketing the device, such as labeling and Good Manufacturing Practice.

    Therefore, I cannot provide the requested information based on the given text.

    To address the prompt, I would need a document that describes:

    • Specific performance metrics for the device (e.g., burst strength, leak rate, absence of holes).
    • Quantitative acceptance criteria for these metrics.
    • Details of a study conducted to test these metrics, including methodology, results, and statistical analysis.
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