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510(k) Data Aggregation

    K Number
    K243967
    Device Name
    ONE Nitrile Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2025-04-08

    (106 days)

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

    Global Protection Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
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    K Number
    K240896
    Device Name
    ONE Nitrile Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2024-08-23

    (144 days)

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

    Global Protection Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
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    K Number
    K223214
    Device Name
    Powder-Free Nitrile Examination Gloves
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2023-09-21

    (339 days)

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

    Global Protection Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder-Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder-Free Nitrile Examination Glove
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    K Number
    K213087
    Device Name
    Natural Rubber Latex Ultrasound Transducer Probe Covers
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2022-06-07

    (256 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Global Protection Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for barrier protection during procedures of endocavity ultrasound examination and diagnosis to help prevent transfer of microorganism, body fluids and particulate material.
    Device Description
    Natural Rubber Latex Ultrasound Transducer Probe Covers
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    K Number
    DEN210034
    Device Name
    ONE Male Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2022-02-23

    (181 days)

    Product Code
    QRZ, ORZ
    Regulation Number
    884.5305
    Why did this record match?
    Applicant Name (Manufacturer) :

    Global Protection Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.
    Device Description
    The ONE Male Condom is a natural rubber latex sheath that completely covers the penis. The condom is straight walled with a reservoir tip and is silicone lubricated. The ONE Male Condom is available in 56 sizes and consists of three different condom types, standard, thin, and fitted.
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    K Number
    K203536
    Device Name
    Male Latex Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2021-09-03

    (274 days)

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

    Global Protection Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
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    K Number
    K193578
    Device Name
    Non-spermicidal Lubricated Male Latex Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2020-08-20

    (241 days)

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

    Global Protection Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-spermicidal Lubricated Male Latex Condoms are intended to prevent pregnancy, HIV/AIDS and other sexually transmitted infections.
    Device Description
    Not Found
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    K Number
    K024324
    Device Name
    LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
    Manufacturer
    GLOBAL PROTECTION CORP.
    Date Cleared
    2003-03-25

    (89 days)

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

    GLOBAL PROTECTION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The (no particular brand name) condom, is intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, it can reduce the risk of pregnancy.
    Device Description
    Non-spermicidal Lubricated male Latex Condom
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    K Number
    K960552
    Device Name
    KNIGHT LIGHT NONLUBRICATED CONDOM
    Manufacturer
    GLOBAL PROTECTION CORP.
    Date Cleared
    1997-11-20

    (651 days)

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

    GLOBAL PROTECTION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KNIGHT LIGHT™ CONTRACEPTIVES, if properly used, are intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, KNIGHT LIGHT™ CONTRACEPTIVES can reduce the risk of pregnancy.
    Device Description
    Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101)
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