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510(k) Data Aggregation

    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
    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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    K Number
    K171172
    Device Name
    Skyn Original Polyisoprene Lubricated Male Condom - Flavored
    Manufacturer
    Ansell Healthcare Products LLC.
    Date Cleared
    2017-08-02

    (103 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ansell Healthcare Products LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
    Device Description
    The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.
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    K Number
    K160974
    Device Name
    Gammex Cut-Resistant Glove Liner
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS LLC
    Date Cleared
    2016-10-28

    (204 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
    The Gammex(R) Cut Resistant Glove Liner is a single use glove liner intended to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.
    Device Description
    Cut resistant under glove liner is a white color liner knitted from an ultrahigh molecular weight polyethylene fiber (UHMWPE) that offers ANSI/ISEA 105 Cut Level Protection against cuts. The liner is knitted using the UHMWPE as the main strengthening component along with nylon and spandex for comfort. The device is a single use device.
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    K Number
    K122720
    Device Name
    LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS LLC
    Date Cleared
    2013-02-22

    (170 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANSELL HEALTHCARE PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LifeStyles® Warm Lovin'™ Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    LifeStyles® Warm Lovin'™ Personal Lubricant is a non-sterile, personal lubricant designed to moisturize and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a clear, nonstaining, long-lasting, warming and biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.
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    K Number
    K122477
    Device Name
    LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS LLC
    Date Cleared
    2013-02-19

    (189 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANSELL HEALTHCARE PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LifeStyles® Luxe™ Premium Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    LifeStyles® Luxe™ Premium Personal Lubricant is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a biocompatible gel-like liquid that lasts longer than hydrous lubricants, without drying out or becoming sticky, and is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.
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    K Number
    K093523
    Device Name
    MICRO-TOUCH NITRILE
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS LLC
    Date Cleared
    2010-03-04

    (111 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
    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 tested for use with chemotherapy drugs.
    Device Description
    Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs meet all of the current specifications of ASTM D6319-00a(2005)e1, Standard Specification for Nitrile Examination Gloves for Medical Application.
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