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510(k) Data Aggregation

    K Number
    K931220
    Device Name
    SPERMICIDAL LUBRICATED CONDOM
    Manufacturer
    MONSYS USA, INC.
    Date Cleared
    1996-05-22

    (1169 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.

    Device Description

    The device in this 510(K) summary is a spermicidal lubricated condom. The condom will be sold under various trade names including Eros, Iris, Amoret, Galant, Gemini, Brillant, Casanova and Galla.

    AI/ML Overview

    This document, K931220, describes a spermicidal lubricated condom and its specifications. It predates the widespread use of AI in medical device evaluation and therefore does not contain information related to AI/ML device performance or evaluation. The concepts of "acceptance criteria for an AI device," "test sets," "ground truth experts," "MRMC studies," or "standalone AI performance" are not applicable to the information provided.

    Therefore, I cannot fulfill the request as it pertains to an AI/ML device. The provided text describes a traditional medical device (condom) and its compliance with established physical and manufacturing standards.

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