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

    NITRILE PATIENT EXAMINATION GLOVE POWDER FREE

    K Number: K982274 · Decision Aug 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    43

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    Basic Information

    Device Name
    NITRILE PATIENT EXAMINATION GLOVE POWDER FREE
    K Number
    K982274
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Asia Pacific Latex Sdn Bhd
    Date Received
    June 29, 1998
    Decision Date
    August 11, 1998
    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 Asia Pacific Latex Sdn Bhd

    K Number Device Name
    K033532 ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
    K033530 ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
    K924357 LATEX PATIENT EXAMINATION GLOVES