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

    Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs

    K Number: K182089 · Decision Jul 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    362

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    Basic Information

    Device Name
    Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
    K Number
    K182089
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Platinum Glove Industries Sdn. Bhd.
    Date Received
    August 2, 2018
    Decision Date
    July 30, 2019
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Platinum Glove Industries Sdn. Bhd.

    K Number Device Name
    K091965 POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED
    K080165 SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
    K051372 POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
    K051317 POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR
    K051318 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)