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510(k) Data Aggregation

    K Number
    K041837
    Device Name
    INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2004-09-24

    (79 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K011253,K023175
    Why did this record match?
    Device Name :

    INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED

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

    The Innolatex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled or contoured with a reservoir tip; nominal length 180mm, nominal width 52mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is colored and flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a Male Latex Condom and does not contain information about acceptance criteria, device performance, or a study proving it meets acceptance criteria for an AI/ML medical device. This document is related to a physical medical device (condom) and discusses its characteristics and intended use, comparing it to predicate devices.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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