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

    POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

    K Number: K013554 · Decision Jan 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    9
    Review Days
    84

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    Basic Information

    Device Name
    POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K Number
    K013554
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Maxter Glove Manufacturing Sdn Bhd
    Date Received
    October 25, 2001
    Decision Date
    January 17, 2002
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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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
    K151390 Powder Free 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
    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