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510(k) Data Aggregation

    K Number
    K170779
    Device Name
    Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
    Manufacturer
    Terang Nusa Sdn Bhd
    Date Cleared
    2017-05-24

    (70 days)

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

    Terang Nusa Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nugard Black Powder Free Latex Examination Glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
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    K Number
    K161932
    Device Name
    Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
    Manufacturer
    Terang Nusa Sdn Bhd
    Date Cleared
    2016-11-28

    (137 days)

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

    Terang Nusa Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Polychloroprene Examination Glove Blue or Pink, non sterile is a disposable device and is made of synthetic rubber intended for medial purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Polychloroprene Examination Glove Blue Powder Free Polychloroprene Examination Glove Pink
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    K Number
    K153510
    Device Name
    Powder Free Polychloroprene Examination Glove Green
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2016-03-21

    (105 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Ask a Question
    K Number
    K151392
    Device Name
    Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2015-09-18

    (115 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgeon's gloves is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    SENSIFLEX PLUS Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
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    K Number
    K140355
    Device Name
    SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2014-11-06

    (267 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgeon's glove is a device made of natural or 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. (as per described in 21 CFR 878,4460)
    Device Description
    SENSIFLEX PLUS Sterile Latex Surgical Gloves Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
    Ask a Question
    K Number
    K110698
    Device Name
    NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2011-12-07

    (293 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Surgeons Glove is a 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. These gloves are tested for use with Chemotherapy Drugs.
    Device Description
    Polychloroprene Synthetic Tan Surgical gloves Powder Free
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    K Number
    K102230
    Device Name
    NUGARD NITILE GREY COLOR
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2010-09-10

    (32 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Non-Sterile Nitrile powder free 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.
    Device Description
    Nitrile Examination Gloves Powder Free Grey Color Non-Sterile
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    K Number
    K102119
    Device Name
    SUR-G GLOV AND MAXITEX
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2010-08-27

    (30 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgeon's gloves are sterile gloves to be worn by surqeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
    Device Description
    Latex Surgical Gloves Powdered, Sterile.
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    K Number
    K083337
    Device Name
    NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2009-01-27

    (76 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K052837
    Device Name
    SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2005-11-21

    (46 days)

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

    TERANG NUSA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Surgeon's glove is a device made of natural rubber intended to be worn by This Surgeon's glove to a so notect a surgical wound from contamination.
    Device Description
    Sensiflex Plus, Polymer Coated Latex Surgical Glove Powder Free, Sterile, Coated with Aloe Vera, contains 50 micrograms or less of total water extractable protein per gram.
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