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510(k) Data Aggregation

    K Number
    K111139
    Device Name
    DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2011-09-02

    (133 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
    Device Description
    The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.
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    K Number
    K082457
    Device Name
    MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2008-11-10

    (76 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
    Device Description
    Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005). Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application. Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs. Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standard | |--------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Dimensions | Meets ASTM D 6319-00a(2005) | | Physical Properties | Meets ASTM D 6319-00a(2005) | | Freedom from Holes | Meets ASTM D 6319-00a(2005)<br>Meets ASTM D 5151-06 | | Powder-Free | Powder content ≤ 2 mg per glove | | Biocompatibility:<br>ISO Skin Irritation Study<br>ISO Maximization Sensitization Study - Extract | No irritation<br>No irritation |
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    K Number
    K042817
    Device Name
    MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2004-12-06

    (55 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
    Device Description
    Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
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    K Number
    K023153
    Device Name
    MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2002-11-13

    (51 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
    Device Description
    Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
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    K Number
    K013603
    Device Name
    MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2001-11-13

    (13 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination.
    Device Description
    Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.
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    K Number
    K013604
    Device Name
    MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2001-11-13

    (13 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultralon® Powder Free Latex Surgical Gloves are to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.
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    K Number
    K011593
    Device Name
    MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2001-06-21

    (28 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
    Device Description
    Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
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    K Number
    K010961
    Device Name
    X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2001-05-31

    (62 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003771
    Device Name
    ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2001-01-16

    (41 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003769
    Device Name
    ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2000-12-22

    (16 days)

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

    ANSELL HEALTHCARE PRODUCTS, INC.

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

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