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510(k) Data Aggregation

    K Number
    K030075
    Device Name
    NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
    Manufacturer
    BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER
    Date Cleared
    2003-03-05

    (56 days)

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

    BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable. The Nitrile Powder-Free Medical Examination Glove (blue) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
    Device Description
    Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
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    K Number
    K022024
    Device Name
    NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
    Manufacturer
    BEST MANUFACTURING COMPANY
    Date Cleared
    2002-08-01

    (42 days)

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

    BEST MANUFACTURING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable. The Nitrile Powder-Free Medical Examination Glove (green) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
    Device Description
    Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
    Ask a Question
    K Number
    K012899
    Device Name
    GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
    Manufacturer
    BEST MANUFACTURING COMPANY
    Date Cleared
    2001-09-18

    (20 days)

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

    BEST MANUFACTURING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Green Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
    Device Description
    Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
    Ask a Question
    K Number
    K012166
    Device Name
    NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
    Manufacturer
    BEST MANUFACTURING COMPANY
    Date Cleared
    2001-08-01

    (21 days)

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

    BEST MANUFACTURING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder-Free Medical Examination Glove (brown) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
    Device Description
    Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
    Ask a Question
    K Number
    K001375
    Device Name
    ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
    Manufacturer
    BEST MANUFACTURING COMPANY
    Date Cleared
    2000-07-25

    (85 days)

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

    BEST MANUFACTURING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993805
    Device Name
    NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)
    Manufacturer
    BEST MANUFACTURING COMPANY
    Date Cleared
    2000-03-10

    (122 days)

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

    BEST MANUFACTURING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
    Device Description
    Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
    Ask a Question
    K Number
    K992170
    Device Name
    N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
    Manufacturer
    BEST MANUFACTURING COMPANY
    Date Cleared
    1999-09-07

    (71 days)

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

    BEST MANUFACTURING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-DEX Nitrile Powder-Free Medical Examination Glove is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable.
    Device Description
    Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids. The proposed device has no donning powder - this has been replaced by a polyurethane base coating, which is fully cross linked with the nitrile film. The proposed device is labeled "Powder-Free".
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