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510(k) Data Aggregation

    K Number
    K021007
    Device Name
    ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2002-07-05

    (99 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultra Preserve With Aloe Vera (Green) 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.". (21CFR 880.6250).
    Device Description
    Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-00 and ASTM D5151-99 requirements.
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    K Number
    K013324
    Device Name
    HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2001-11-29

    (55 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensi Grip® Surgical Glove is a disposable device intended for medical use within hospitals and other healthcare facilities during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn on the operating room personnel's hand to protect a surgical wound from contamination.
    Device Description
    Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching and washing process removes traces of chemical accelerants That may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D3577-00 and ASTM D5151-99 requirements.
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    K Number
    K013016
    Device Name
    TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2001-10-19

    (42 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The True Advantage Non-Sterile Powder Free Purple Nitrile Patient 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.". (21CFR 880.6250).
    Device Description
    Nitrile films form a 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 movements necessary for a medical procedure. Nitrile Rubber is known to create a barrier to bloodborne pathogens and and body fluids. ASTM D6319 conforming tensile properties create a glove that Is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D6319-00 and ASTM D5151-99 requirements.
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    K Number
    K013286
    Device Name
    CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2001-10-12

    (10 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cymunvera Powder Free Green Natural Rubber Latex Examination Glove lined with Aloe Vera is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
    Device Description
    Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The natural rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of Proteins and chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D 3578-00a and ASTM D5151-92 requirements. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Powder free gloves eliminate issues of powder contamination.
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    K Number
    K011497
    Device Name
    CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2001-07-10

    (56 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002718
    Device Name
    ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2001-05-01

    (243 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K004048
    Device Name
    SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2001-02-06

    (39 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002719
    Device Name
    FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2001-01-26

    (148 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002720
    Device Name
    FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2000-11-09

    (70 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000745
    Device Name
    SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Date Cleared
    2000-05-03

    (56 days)

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

    TILLOTSON HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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