Search Filters

Search Results

Found 21 results

510(k) Data Aggregation

    K Number
    K162095
    Device Name
    Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.,
    Date Cleared
    2016-11-02

    (97 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
    Device Description
    Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
    Ask a Question
    K Number
    K143289
    Device Name
    NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2015-08-18

    (274 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    Non-Sterile, Powder Free Nitrile Examination Gloves – Orange, Green, Blue and Violet Color Color meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
    Ask a Question
    K Number
    K143055
    Device Name
    Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2015-02-12

    (112 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, and Vanilla meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
    Ask a Question
    K Number
    K142283
    Device Name
    Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2015-01-16

    (154 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
    Ask a Question
    K Number
    K133123
    Device Name
    NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2014-05-30

    (242 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K111248
    Device Name
    NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2011-12-01

    (212 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient an examiner.
    Device Description
    Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs, meets all the current specifications listed under ASTM Specifications D6319-05 , Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05, Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs.
    Ask a Question
    K Number
    K101820
    Device Name
    NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2011-03-03

    (246 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K061553
    Device Name
    NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2006-07-17

    (42 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Non-Sterile, Powder-Free, Black Nitrile Examination Glove 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.
    Device Description
    Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination Gloves for Medical Application.
    Ask a Question
    K Number
    K052502
    Device Name
    NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2005-11-18

    (66 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves 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.
    Device Description
    Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 and FDA Water leak test.
    Ask a Question
    K Number
    K033887
    Device Name
    NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN. BHD.
    Date Cleared
    2004-03-02

    (78 days)

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

    YTY INDUSTRY (MANJUNG) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a563 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are blue in colour and are powder free.
    Ask a Question

    Page 1 of 3