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510(k) Data Aggregation

    K Number
    K172923
    Device Name
    Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
    Manufacturer
    Top Glove Sdn. Bhd.
    Date Cleared
    2018-04-26

    (213 days)

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

    Top Glove Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove 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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs.
    Device Description
    Nitrile Examination Powder Free Glove, White, Black, Orange Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
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    K Number
    K122999
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    2012-11-30

    (64 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove 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. in addition, these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: | | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in<br>Minutes, 0.01 ug/cm2/minute | |---|--------------------------------------------------|-----------------------------------------------------------------------| | 1 | Cisplatin, 1.0 mg/ml (1,000ppm) | >240 | | 2 | Cyclophosphamide (Cytoxan),20.0mg/ml (20,000ppm) | >240 | | 3 | Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 | | 4 | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 | | 5 | Etoposide (Toposar), 20.0 mg/ml (20,000)ppm | >240 | | 6 | Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 | | 7 | Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 | | 8 | Carmustine (BCNU)3.3mg/ml(3,300ppm) | 0.9 | | 9 | Thiotepa, 10.0mg/ml (10,000ppm) | 0.05 | The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes > Carmustine (BCNU)3.3mg/ml(3,300ppm) Thiotepa, 10.0mg/ml ( 10,000ppm)
    Device Description
    Not Found
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    K Number
    K023974
    Device Name
    ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    2003-02-13

    (73 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
    Device Description
    POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND - PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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    K Number
    K021855
    Device Name
    TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    2002-08-05

    (60 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Latex examination powderfree gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Not Found
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    K Number
    K993664
    Device Name
    SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    2000-01-11

    (74 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthetic Vinyl Medical Examination Powdered Gloves are worn on the hands of Health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
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    K Number
    K993452
    Device Name
    GREEN POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    1999-12-20

    (68 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.
    Device Description
    Powdered Green Latex Examination Glove
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    K Number
    K993605
    Device Name
    PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    1999-12-20

    (56 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pepper Green Mint Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Not Found
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    K Number
    K993680
    Device Name
    SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    1999-12-13

    (42 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
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    K Number
    K990690
    Device Name
    POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    1999-05-20

    (78 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
    Device Description
    Polymer Coated Powder-Free Latex Examination Gloves
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    K Number
    K990468
    Device Name
    LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    1999-04-27

    (70 days)

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

    TOP GLOVE SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALITE CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
    Device Description
    POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELLING (100 MICROGRAM OR LESS)
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