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510(k) Data Aggregation

    K Number
    K172864
    Device Name
    Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    Manufacturer
    Maxter Glove Manufacturing Sdn Bhd
    Date Cleared
    2018-05-02

    (224 days)

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

    Maxter Glove Manufacturing Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
    Device Description
    These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
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    K Number
    K151390
    Device Name
    Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2016-05-02

    (342 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) ------------------------------------------|----------------------------------------------- Cisplatin, 1.0mg/ml | >240 Cyclophosphamide (Cytoxan), 20mg/ml | >240 Carmustine (BCNU), 3.3mg/ml | 1.0 Dacarbazine (DTIC), 10.0mg/ml | >240 Doxorubicin Hydrochloride, 2.0mg/ml | >240 Etoposide (Toposar), 20.0mg/ml | >240 Fluorouracil, 50.0mg/ml | >240 Paclitaxel (Taxol), 6.0mg/ml | >240 Thiotepa, 10.0mg/ml | 31.3 Methotrexate ,25mg/ml | >240 Mitomycin C, 0.5mg/ml | >240 Vincristine Sulfate, 1.0mg/ml | >240 Ifosfamide, 50.0mg/ml | >240 Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml: 1.0 minute Thiotepa, 10.0mg/ml: 31.3 minutes
    Device Description
    These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
    Ask a Question
    K Number
    K113100
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2012-02-06

    (110 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) -----------------------------------------|--------------------------------------------- Cisplatin, 1.0mg/ml (1,000ppm) | >240 Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 0.53 Dacarbazine (DTIC), 10.0mg/ml (10,000ppm)| >240 Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 Fluorouracil, 50.0mg/ml (50,000ppm) | >240 Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 Thiotepa, 10.0mg/ml (10,000ppm) | 75.54 Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm) Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
    Device Description
    Not Found
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    K Number
    K040176
    Device Name
    MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2004-02-24

    (29 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Not Found
    Ask a Question
    K Number
    K032501
    Device Name
    MAXTER STERILE POWDER FREE SURGICAL GLOVES
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2003-10-17

    (65 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Sterile Powder Free Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Sterile Powder Free Latex Surgical Gloves
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    K Number
    K032467
    Device Name
    MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2003-10-10

    (60 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Sterile Powdered Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Sterile Powdered Latex Surgical Gloves
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    K Number
    K013498
    Device Name
    CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2002-01-17

    (87 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Chlorinated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per gram.
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    K Number
    K013554
    Device Name
    POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2002-01-17

    (84 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Polymer Coated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per g.
    Ask a Question
    K Number
    K013443
    Device Name
    POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2001-11-29

    (43 days)

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

    MAXTER GLOVE MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Powdered Latex Medical Examination Gloves with 150 Micrograms or Less of Total Water Extractable Protein per Gram of Glove.
    Ask a Question

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