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

    NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs

    K Number: K152222 · Decision Apr 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    3
    Review Days
    258

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    Basic Information

    Device Name
    NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
    K Number
    K152222
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gmp Medicare Sdn Bhd (F25)
    Date Received
    August 7, 2015
    Decision Date
    April 21, 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 Gmp Medicare Sdn Bhd (F25)

    K Number Device Name
    K182382 Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
    K172867 Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange