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510(k) Data Aggregation

    K Number
    K231902
    Device Name
    GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
    Manufacturer
    Ansell Healthcare
    Date Cleared
    2023-10-20

    (114 days)

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

    Ansell Healthcare

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test chemotherapy drug and concentration Minimum breakthrough detection time in minutes Bleomycin (15.0 mg/ml) >240 Busulfan (6.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Carmustine (3.3 mg/ml) 24.1 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Cytarabine HCl (100.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Daunorubicin HCl (5.0 mg/ml) >240 Docetaxel (10.0 mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Epirubicin (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fludarabine (25.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Gemcitabine (38.0 mg/ml) >240 Idarubicin (1.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Irinotecan (20.0 mg/ml) >240 Mechlorethamine HCI (1.0 mg/ml) >240 Melphalan (5.0mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0mg/ml) >240 Oxaliplatin (2.0 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Rituximab (10.0 mg/ml) >240 ThioTEPA (10.0 mg/ml) 26.0 Vincristine Sulfate (1.0 mg/ml) >240 Warning: Do not use with Carmustine or ThioTEPA
    Device Description
    Gammex PI Hybrid Micro Surgical Gloves are sterile and disposable devices. The gloves are made of a synthetic rubber polyisoprene and neoprene blend. Ansell has performed independent laboratory testing to support use with Chemotherapy Drugs and Non-Pyrogenic claims. The glove has a shelf life of 3 years, is brown in color and comes in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Each size is assigned with a model number.
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    K Number
    K230079
    Device Name
    Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
    Manufacturer
    Ansell Healthcare Products, LLC.
    Date Cleared
    2023-08-23

    (225 days)

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

    Ansell Healthcare Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.
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    K Number
    K213289
    Device Name
    Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
    Manufacturer
    Ansell Healthcare Products, LLC
    Date Cleared
    2023-05-26

    (602 days)

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

    Ansell Healthcare Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
    Device Description
    Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.
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    K Number
    K212148
    Device Name
    Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
    Manufacturer
    Ansell Healthcare Products LLC
    Date Cleared
    2022-03-10

    (244 days)

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

    Ansell Healthcare Products LLC

    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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: 45.4 minutes and Thiotepa: 23.5 minutes. Warning: Do not use with Carmustine or Thiotepa.
    Device Description
    Microflex 73-743 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is a non-sterile, single use only, disposable, powder free examination gloves. Characteristics: - . Ambidextrous with beaded cuff and straight fingers - Finger-textured . - . Blue colored - Five (5) sizes – extra-small, small, medium, large, and extra-large - . Tested against chemotherapy drugs High levels of ozone will degrade rubber material of the glove; therefore, the glove should be protected from ozone in particular. The glove is designed to meet the specifications of ASTM D6977-19, Standard Specification for Polychloroprene Examination Gloves for Medical Application.
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    K Number
    K210401
    Device Name
    Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Ansell Healthcare Products LLC
    Date Cleared
    2021-06-13

    (123 days)

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

    Ansell Healthcare Products LLC

    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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes (Blue), 49.6 minutes (Green), 27.6 minutes (Black). Warning: Do not use with Carmustine.
    Device Description
    Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable, powder free examination gloves are made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the gloves to make donning easy. Characteristics: - . Ambidextrous with beaded cuff and straight fingers - . Finger-textured - Blue, green, or black colored . - . Four (4) sizes - small, medium, large, and extra-large - . Tested against chemotherapy drugs and fentanyl citrate High levels of ozone will degrade rubber material of the gloves; therefore, the gloves should be protected from ozone in particular. The gloves are designed to meet the specifications of ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K200671
    Device Name
    Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
    Manufacturer
    Ansell Healthcare Products LLC
    Date Cleared
    2020-06-19

    (98 days)

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

    Ansell Healthcare Products LLC

    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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Colored Tested for Use with Chemotherapy Drugs, Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Green Colored Tested for Use with Chemotherapy Drugs, Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy.
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    K Number
    K190018
    Device Name
    Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
    Manufacturer
    Ansell Healthcare Products, LLC.
    Date Cleared
    2019-05-23

    (139 days)

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

    Ansell Healthcare Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents
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    K Number
    K182948
    Device Name
    Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
    Manufacturer
    Ansell Healthcare Products, LLC.
    Date Cleared
    2019-03-22

    (150 days)

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

    Ansell Healthcare Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gammex PI Hybrid Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and effective for handling chemotherapy agents.
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    K Number
    K171375
    Device Name
    Gammex PI Breach Detect Powder Free Surgical Glove
    Manufacturer
    Ansell Healthcare Products LLC
    Date Cleared
    2018-02-06

    (272 days)

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

    Ansell Healthcare Products LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. When used as an underglove, the glove is intended to promote visibility of a fluid that breaches/enters the glove via an increased spreading rate.
    Device Description
    Gammex Pl Breach Detect Powder Free Surgical Glove is a sterile, green in color, single use disposable powder free surgical glove. The glove is made of synthetic polyisoprene rubber. A polymer is applied to the inner surface of the glove to make donning easy. The glove's outer surface is coated with a surface-active agent and when used as an under-glove, this coating and the glove's green color can improve visibility of a glove breach by promoting wetting of the glove surface and spreading of bodily fluid penetrating the breach.
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    K Number
    K171737
    Device Name
    Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
    Manufacturer
    Ansell Healthcare Products LLC
    Date Cleared
    2017-12-29

    (200 days)

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

    Ansell Healthcare Products LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.
    Device Description
    The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating (containing glycerine) is applied on top of the polymer coating on the glove inner surface.. Characteristic: - Ambidextrous with beaded cuff and straight fingers - Finger-textured, - White colored - Featuring inner coating of polyacrylic polymer coating and HydraSoft™ coating. - . Five (5) sizes – extra-small, small, medium, large, and extra-large.
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