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510(k) Data Aggregation

    K Number
    K982924
    Device Name
    DUREX SENSIDOM LATEX CONDOM
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-11-16

    (88 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONDON INTL. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durex Condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is nipple-ended with minimal dimensions of Width: 52 mm, Length: 160 mm min., Thickness: 0.03 mm min.
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    K Number
    K983380
    Device Name
    DUREX LUBRAGEL LATEX CONDOM
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-11-16

    (52 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONDON INTL. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durex Condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is nipple-ended with minimal dimensions of Width: 52 mm, Length: 160 mm min., Thickness: 0.03 mm min.
    Ask a Question
    K Number
    K980174
    Device Name
    DUREX COLORS AND SCENTS
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-08-13

    (205 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONDON INTL. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A latex rubber condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and the spread of sexually transmitted diseases.
    Device Description
    Not Found
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    K Number
    K980785
    Device Name
    STERILE, POWDERFREE LATEX EXAMINATION GLOVE
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-06-10

    (100 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONDON INTL. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An examination glove is a disposable device intended for medical purposes "An examinon Eroro is a carperation or finger to prevent contamination between patient and examiner."
    Device Description
    Regent™ Safetex™ Sterile Latex Medical Examination Glove, Powder-Free,Less than 50mcg/gram Total Protein
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    K Number
    K980319
    Device Name
    DUREX ULTRA COMFORT
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-05-20

    (113 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONDON INTL. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Latex Rubber Condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.
    Device Description
    Latex Rubber Condom
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    K Number
    K980204
    Device Name
    DUREX LATEX CONDOMS
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-04-17

    (87 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONDON INTL. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A latex condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.
    Device Description
    Rubber Latex Condom (Magnesium and Calcium Carbonate Finishing agents
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