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

    Patient Examination Gloves

    K Number: K230777 · Decision Oct 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    199

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    Basic Information

    Device Name
    Patient Examination Gloves
    K Number
    K230777
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3A Glove Sdn. Bhd.
    Date Received
    March 21, 2023
    Decision Date
    October 6, 2023
    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 3A Glove Sdn. Bhd.

    K Number Device Name
    K230847 Chemotherapy Gloves