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510(k) Data Aggregation

    K Number
    K240361
    Device Name
    Power Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Power Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Power Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., Ltd.
    Date Cleared
    2024-04-04

    (58 days)

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

    Hebei Titans Hongsen Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves 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
    Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The difference between the devices is the color of powder free green nitrile examination gloves is green, the color of powder free pink nitrile examination gloves is pink, the color of powder free purple nitrile examination gloves is purple. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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    K Number
    K223895
    Device Name
    Disposable Medical Nitrile Examination Gloves
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., Ltd.
    Date Cleared
    2023-03-23

    (85 days)

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

    Hebei Titans Hongsen Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.
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    K Number
    K221374
    Device Name
    Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., Ltd.
    Date Cleared
    2022-10-26

    (167 days)

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

    Hebei Titans Hongsen Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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    K Number
    K212097
    Device Name
    Disposable medical surgical mask
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., LTD
    Date Cleared
    2021-08-18

    (43 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hebei Titans Hongsen Medical Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable medical surgical mask is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.
    Device Description
    The Disposable medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile. The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric. The Disposable medical surgical mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated steel wire. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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    K Number
    K211229
    Device Name
    Vinyl compound examination gloves
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., LTD.
    Date Cleared
    2021-07-29

    (97 days)

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

    Hebei Titans Hongsen Medical Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vinyl compound examination gloves 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, Vinyl compound examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is Blue. The design of proposed device is addressing the standards as ASTM D6124. ASTM D5151, and ASTM D5250. The proposed device is not provided as sterilized. The proposed device is made of vinyl chloride.
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    K Number
    K182043
    Device Name
    Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., LTD.
    Date Cleared
    2018-09-21

    (53 days)

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

    Hebei Titans Hongsen Medical Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) 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 is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
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    K Number
    K181130
    Device Name
    Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., LTD.
    Date Cleared
    2018-08-10

    (102 days)

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

    Hebei Titans Hongsen Medical Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Blue Nitrile Examination 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 Examination 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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