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510(k) Data Aggregation

    K Number
    K202003
    Device Name
    Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
    Date Cleared
    2021-02-24

    (219 days)

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

    GMP Medicare SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
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    K Number
    K182382
    Device Name
    Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
    Date Cleared
    2019-08-29

    (363 days)

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

    GMP Medicare SDN BHD (F25)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
    Device Description
    Not Found
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    K Number
    K172867
    Device Name
    Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
    Date Cleared
    2018-05-10

    (232 days)

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

    GMP MEDICARE SDN BHD (F25)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. 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.
    Device Description
    Nitrile Examination Powder Free Glove, Black; Nitrile Powder Free Glove, Orange
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    K Number
    K163017
    Device Name
    Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
    Date Cleared
    2017-03-22

    (145 days)

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

    GMP MEDICARE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
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    K Number
    K152222
    Device Name
    NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
    Date Cleared
    2016-04-21

    (258 days)

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

    GMP MEDICARE SDN BHD (F25)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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: Chemotherapy Drug Permeation - The following chemicals have been tested with these gloves | Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|---------------|----------------------------------------| | Carmustine (BCNU) | 3.3mg/ml | *10.1 | | Cisplatin | 1.0mg/ml | >240 | | Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 | | 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 | *20.2 | | Amethopterin Hydrate | 25.0mg/ml | >240 | | Methotrexate | 25.0mg/ml | >240 | | Mitomycin C | 0.5mg/ml | >240 | | Vincristine Sulfate | 1.0mg/ml | >240 | * Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.1 minutes and Thiotepa: 20.2 minutes
    Device Description
    Nitrile Blue Powder Free 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.
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