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510(k) Data Aggregation

    K Number
    K102790
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2010-11-29

    (63 days)

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

    PERUSAHAAN GETAH ASAS SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K042805
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2004-12-16

    (65 days)

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

    PERUSAHAAN GETAH ASAS SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.
    Device Description
    The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83
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    K Number
    K032374
    Device Name
    POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-10-22

    (82 days)

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

    PERUSAHAAN GETAH ASAS 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. Tested for use with Chemotherapy Drugs.
    Device Description
    Powder-free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored
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    K Number
    K031625
    Device Name
    POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-08-01

    (66 days)

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

    PERUSAHAAN GETAH ASAS 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
    Powder-free Barrier-Pro™ Co-polymer Patient Examination Clove, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Mcthacrylic Acid Co-polymer Rubber (h)Barrier-ProTM is a registered trade mark of Dow Reichhold Specialty Latex LLC
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    K Number
    K031768
    Device Name
    BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-08-01

    (53 days)

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

    PERUSAHAAN GETAH ASAS 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
    Barrier-Pro™ Co-polymer Patient Examination Glove, Powdered, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Methacrylic Acid Co-polymer Rubber (b)Barrier-Pro™ is a registered trade mark of Dow Reichhold Specialty Latex LLC
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    K Number
    K031414
    Device Name
    POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-06-26

    (52 days)

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

    PERUSAHAAN GETAH ASAS 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
    Powder-free Latex Patient Examination Glove, White (non-colored) or Blue Colored, with extractable protein content labelling claim (50 microgram per gram of glove or less)
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    K Number
    K031591
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-06-26

    (36 days)

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

    PERUSAHAAN GETAH ASAS 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
    Powder-free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored
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    K Number
    K031021
    Device Name
    CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-06-13

    (74 days)

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

    PERUSAHAAN GETAH ASAS 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
    Polymer-Coated, Powder-free, Latcx Patient Examination Glove with Protein Labelling Claim (contain 50 microgram or less of total water extractable protein per gram)
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    K Number
    K030331
    Device Name
    ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-03-21

    (49 days)

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

    PERUSAHAAN GETAH ASAS 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
    On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)
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    K Number
    K030333
    Device Name
    LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-03-21

    (49 days)

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

    PERUSAHAAN GETAH ASAS 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
    Latex Patient Examination Glove, Powdcred Type II, Low Modulus, with extractable protein content labelling claim (200 microgram per gram of glove or less)
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