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510(k) Data Aggregation

    K Number
    K123126
    Device Name
    MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2014-06-04

    (608 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
    Device Description
    Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.
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    K Number
    K132802
    Device Name
    MOTEX POWDERED NITRILE SURGICAL GLOVES
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2014-05-21

    (257 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
    Device Description
    Motex Powdered Nitrile Surgical Gloves are made of synthetic rubber. They are sterilized by radiation, and intended to be used in surgery to prevent the cross contamination between patient and user.
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    K Number
    K122557
    Device Name
    MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2013-10-03

    (407 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
    Device Description
    Motex Powder-free Nitrile Surgical Gloves are made of synthetic rubber. Thev are sterilized by radiation, and intended for be used in surgery for patient and user.
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    K Number
    K063757
    Device Name
    MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2007-07-27

    (220 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder). Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning. The characteristics are summarized below compared to ASTM and ISO standards to the predicate device: Characteristic: Dimensions, Standard: meets ASTM D 3577-06, Characteristic: Physical Properties, Standard: meets ASTM D 3577-06, Characteristic: Freedom from Holes, Standard: meets ASTM D 3577-06, Characteristic: Biocompatibility, Standard: meets ISO10993-5/-10 Characteristic: Sterilization Validation, Standard: meets ISO11137
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    K Number
    K041276
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2004-08-20

    (100 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).
    Device Description
    Nitrile rubber is impermeable to water and body fluids under normal conditions of use. The physical properties of the nitrile rubber enable it to conform to the hand for medical procedures. Nitrile rubber is known to form a superior barrier to bloodborne pathogens and meet physical properties for medical examination procedures as specified in ASTM D6319-00ae3.
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    K Number
    K030207
    Device Name
    NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2003-05-02

    (101 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nitrile Powder-free Examination Glove, ProBlue is a disposable device made of synthetic materials intended for medical purposes that are worn on the examiner's hand or finger(s) to prevent contamination of potentially infectious materials between patient and examiner.
    Device Description
    Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735
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    K Number
    K020837
    Device Name
    MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2002-12-02

    (263 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    disposable device made of natural rubber latex material that may bear a trace amount of glove powder
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    K Number
    K013261
    Device Name
    MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
    Manufacturer
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Date Cleared
    2001-11-29

    (59 days)

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

    SHANGHAI MOTEX HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
    Device Description
    Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
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