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

    Powder free nitrile examination glove- blue, non-sterile

    K Number: K212804 · Decision Dec 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    Powder free nitrile examination glove- blue, non-sterile
    K Number
    K212804
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hong Seng Gloves Sdn Bhd
    Date Received
    September 2, 2021
    Decision Date
    December 1, 2021
    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 Hong Seng Gloves Sdn Bhd

    K Number Device Name
    K221164 Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
    K212801 Powder free nitrile examination glove- black, non sterile
    K212802 powder free nitrile examination glove - white, non-sterile