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510(k) Data Aggregation

    K Number
    K163146
    Device Name
    POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
    Manufacturer
    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
    Date Cleared
    2017-02-13

    (96 days)

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

    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device 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
    The proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
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    K Number
    K150340
    Device Name
    POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
    Manufacturer
    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
    Date Cleared
    2015-06-18

    (127 days)

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

    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device, POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. Powder Free Nitrile Patient Examination Gloves are made of Nitrile rubber; available in four different colors (White, Cobalt Blue, Black, and Ice Blue) and five different sizes (XS-XL). The subject device is provided non-sterile and is a barrier.
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    K Number
    K140989
    Device Name
    POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)
    Manufacturer
    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
    Date Cleared
    2014-12-22

    (249 days)

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

    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powder free nitrile surgical glove, white color (Brand Name: Titanfine), is a sterile and single use device made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
    Device Description
    Surgical glove is a disposable device worn on the surgical room personnel's hand or finger to prevent contamination during surgical procedures. The principle of operation is to provide a physical barrier between the surgical personnel's hands and the patient's open wound. The powder free nitrile surgical gloves described in this submission are made of synthetic nitrile rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have white color and are single use. The powder free nitrile surgical gloves described in this submission are tested for dimension, percent elongation, tensile, tensile at 500% elongation, free of pinholes, residue powder, water soluble proteins. The test results conform to related requirements in ASTM 3577-2009. The powder free nitrile surgical gloves described in this submission are also tested biocompatibility per ISO 10993-10. The test results conform to related requirements in the standard. The product sterilization is performed using radiation and the procedure is validated per ISO 11137-2: 2006.
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    K Number
    K140988
    Device Name
    POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)
    Manufacturer
    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
    Date Cleared
    2014-08-12

    (117 days)

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

    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine), 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
    Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) are made of natural rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have yellow color.
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    K Number
    K131440
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
    Manufacturer
    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
    Date Cleared
    2013-09-25

    (128 days)

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

    HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Titan powder free nitrile patient examination glove, blue color, 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. It has blue color and is sold as non sterile.
    Device Description
    Powder free nitrile examination gloves are made of synthetic nitrile rubber, and are non sterile that meets all of the requirements of ASTM standard D 6319-10, except for sterility requirements. They have blue color.
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