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510(k) Data Aggregation

    K Number
    K062730
    Device Name
    NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
    Manufacturer
    BIOGREEN MEDICAL SDN. BHD.
    Date Cleared
    2006-10-05

    (22 days)

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

    NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS

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

    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    Male Natural Rubber Latex Condom

    AI/ML Overview

    This is a 510(k) clearance letter for a Male Natural Rubber Latex Condom, not a study describing the approval of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment for an AI/ML device is not applicable and cannot be extracted from the provided text.

    The document discusses the regulatory clearance process for a medical device (condom) based on its substantial equivalence to a predicate device, and it outlines general regulatory requirements under the Federal Food, Drug, and Cosmetic Act.

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