Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K121592
    Device Name
    POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
    Date Cleared
    2013-01-18

    (232 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free nitrile 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. The tested chemotherapy drugs and their breakthrough detection time are as follows : | Chemotherapy Drugs & concentration | Average Breakthrough Detection Time | |----------------------------------------|-------------------------------------| | Carmustine (BCNU), 3300ppm | 60.2 | | Cisplatin, 1000ppm | > 240 min | | Cyclophosphamide (Cytoxan), 20,000 ppm | > 240 min | | Dacarbazine (DTIC), 10,000 ppm | > 240 min | | Doxorubicin Hydrochloride, 2000 ppm | > 240 min | | Etoposide (Toposar), 20,000 ppm | > 240 min | | Fluorouracil, 50,000 ppm | > 240 min | | Ifosfamide, 50,000 ppm | > 240 min | | Methotrexate, 25,000 ppm | > 240 min | | Mitomycin C, 500 ppm | > 240 min | | Mitoxantrone, 2000 ppm | > 240 min | | Paclitaxel (Taxol), 6000 ppm | > 240 min | | Thiothepa, 10,000 ppm | 105.6 | | Vincristine Sulfate, 1000 ppm | > 240 min | Please note that the following drugs have low permeation times: Carmustine - 60.2 minutes Thiothepa - 105.6 minutes
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K121594
    Device Name
    COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
    Date Cleared
    2012-10-25

    (147 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free latex 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
    Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2
    Ask a Question

    Ask a specific question about this device

    K Number
    K121591
    Device Name
    FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
    Date Cleared
    2012-10-11

    (133 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free latex examination glove with vanilla, grape and strawberry flavor 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
    Flavoured, Powder Free And Polymer Coated Latex Examination Glove (Vanilla, Grape and Strawberry) With A Protein Claim Of Less Than 50ug/dm2
    Ask a Question

    Ask a specific question about this device

    K Number
    K121192
    Device Name
    NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
    Date Cleared
    2012-08-03

    (106 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free nitrile 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
    Colored Powder Free And Polymer Coated Nitrile Examination Glove (White, Blue and Black)
    Ask a Question

    Ask a specific question about this device

    K Number
    K100694
    Device Name
    COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
    Date Cleared
    2010-06-25

    (106 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
    Device Description
    A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
    Ask a Question

    Ask a specific question about this device

    K Number
    K013317
    Device Name
    TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    2001-12-17

    (74 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Tekmedic Powder-Free Latex Patient Examination Gloves with Aloe Vera Coating and Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram
    Ask a Question

    Ask a specific question about this device

    K Number
    K000555
    Device Name
    TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
    Date Cleared
    2000-04-12

    (54 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K994250
    Device Name
    TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    2000-02-07

    (53 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Tekmedic Powder-Free Latex Examination Gloves, with Protein Labeling Claim (50 Micrograms or Less)
    Ask a Question

    Ask a specific question about this device

    K Number
    K971949
    Device Name
    POWDER-FREE PATIENT EXAMINATION GLOVES
    Date Cleared
    1997-07-28

    (61 days)

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

    TEKMEDIC (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand. of health care and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Tekmedic Powder-Free LATEX Examination Gloves
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1