BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

    K Number: K151390 · Decision May 2, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    9
    Review Days
    342

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    Basic Information

    Device Name
    Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
    K Number
    K151390
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maxter Glove Manufacturing Sdn Bhd
    Date Received
    May 26, 2015
    Decision Date
    May 2, 2016
    Product Code
    LZC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZC Medical Glove, Specialty

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    Other Clearances by Maxter Glove Manufacturing Sdn Bhd

    K Number Device Name
    K172864 Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    K113100 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K040176 MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
    K032501 MAXTER STERILE POWDER FREE SURGICAL GLOVES
    K032467 MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
    K013554 POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K013498 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K013443 POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2