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510(k) Data Aggregation

    K Number
    K162405
    Device Name
    Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)
    Manufacturer
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Date Cleared
    2017-03-28

    (211 days)

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

    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
    Device Description
    The proposed devices are Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim. The gloves are available in two colors: blue and white. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K110297
    Device Name
    POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
    Manufacturer
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Date Cleared
    2011-06-15

    (134 days)

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

    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or finger(s) to prevent contamination between patient and examiner.
    Device Description
    POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
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    K Number
    K101917
    Device Name
    COMFORT RUBBER GLOVES IND.SDN.BHD.
    Manufacturer
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Date Cleared
    2010-10-29

    (112 days)

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

    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device made of natural rubber latex material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
    Device Description
    POWDER FREE LATEX (PINK) EXAMINATION GLOVES. A powder-free patient examination glove is a disposable device made of natural rubber latex material.
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    K Number
    K002065
    Device Name
    PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
    Manufacturer
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Date Cleared
    2000-08-22

    (46 days)

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

    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001042
    Device Name
    COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE
    Manufacturer
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Date Cleared
    2000-05-23

    (53 days)

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

    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K974424
    Device Name
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Manufacturer
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Date Cleared
    1998-04-23

    (150 days)

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

    COMFORT RUBBER GLOVES INDUSTRIES 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 finger to prevent contamination between patient and examiner.
    Device Description
    Comfort Powderfree Latex Examination Glove with Latex ("Powder-free") 80LYY Protein Content Labeling Claim (50 micrograms or less)
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