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

    Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile

    K Number: K221378 · Decision Sep 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    1
    Review Days
    141

    Basic Information

    Device Name
    Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
    K Number
    K221378
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tec Gloves Industry (M) Sdn.Bhd.
    Date Received
    May 12, 2022
    Decision Date
    September 30, 2022
    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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