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

    THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE

    K Number: K162626 · Decision Mar 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    1
    Review Days
    192

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    Basic Information

    Device Name
    THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
    K Number
    K162626
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Top Quality Glove Sdn. Bhd
    Date Received
    September 20, 2016
    Decision Date
    March 31, 2017
    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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