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510(k) Data Aggregation

    K Number
    K012664
    Device Name
    ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-11-09

    (88 days)

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

    ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT

    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

    Ultra Thick Male Latex Condom with Silicone Lubricant

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a male latex condom. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on the substantial equivalence determination for regulatory clearance.

    Therefore, I cannot extract the requested information from this document.

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