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510(k) Data Aggregation

    K Number
    K170198
    Device Name
    Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
    Manufacturer
    Cardinal Health, Inc.
    Date Cleared
    2017-06-15

    (143 days)

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

    Cardinal Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time,<br>0.01 µg/cm²/minute | |-----|-------------------------------------|------------------------------------------------------------| | 1. | Carmustine (BCNU) (3.3 mg/ml) | 17.9 | | 2. | Cisplastin, (1.0 mg/ml) | >240 | | 3. | Cyclophosphamide (20 mg/ml) | >240 | | 4. | Doxorubicin HCl (2.0 mg/ml) | >240 | | 5. | Etoposide (Toposar) (20 mg/ml) | >240 | | 6. | Fluorouracil (50 mg/ml) | >240 | | 7. | Methotrexate (25 mg/ml) | >240 | | 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | 9. | Thiotepa (10 mg/ml) | 40.3 | | 10. | Vincristine Sulfate (1.0 mg/ml) | >240 | WARNING: Do not use with Carmustine (BCNU) (3.3 mg/m1) CAUTION: Testing showed an average breakthrough time of 40.3 minutes with Thiotepa (10 mg/ml).
    Device Description
    The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene and neoprene, which are synthetic rubber latex. The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.
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    K Number
    K160411
    Device Name
    Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2016-07-25

    (160 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile.
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    K Number
    K160875
    Device Name
    Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2016-07-11

    (103 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene, which is a synthetic rubber latex, and is brown in color. The glove is coated with hydrogel polymer coating. The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only. This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery
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    K Number
    K153316
    Device Name
    Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
    Manufacturer
    Cardinal Health, Inc.
    Date Cleared
    2016-05-12

    (177 days)

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

    Cardinal Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating and is yellow in color. The glove are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.
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    K Number
    K122696
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2013-01-31

    (149 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.
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    K Number
    K121897
    Device Name
    PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2012-07-27

    (28 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.
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    K Number
    K120934
    Device Name
    PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2012-05-23

    (56 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.
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    K Number
    K111878
    Device Name
    PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2011-09-29

    (90 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This powder-free surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). The glove is coated with emollient coating (containing Glycerol. Gluconolactone, D-Sorbitol and Provitamin-B). The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down.
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    K Number
    K110272
    Device Name
    STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2011-06-08

    (128 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    The proposed device is a disposable device. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured using exact same material used in the currently cleared device, Esteem SMT glove (K093300) that has been legally marketed by Cardinal Health. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.
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    K Number
    K111015
    Device Name
    STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2011-05-06

    (25 days)

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

    CARDINAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile.
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