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

    Sterile Surgical Powder Free Latex Glove

    K Number: K221424 · Decision Jan 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    255

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    Basic Information

    Device Name
    Sterile Surgical Powder Free Latex Glove
    K Number
    K221424
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    New Era Medicare Sdn. Bhd.
    Date Received
    May 16, 2022
    Decision Date
    January 26, 2023
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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    Other Clearances by New Era Medicare Sdn. Bhd.

    K Number Device Name
    K230314 Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
    K221667 Non Sterile Powder Free Latex Examination Glove