BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇳 India

    Sterile Nitrile Surgical Gloves, Powder-free

    K Number: K170515 · Decision Jun 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    108

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    Basic Information

    Device Name
    Sterile Nitrile Surgical Gloves, Powder-free
    K Number
    K170515
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Primus Gloves Pvt Limited
    Date Received
    February 21, 2017
    Decision Date
    June 9, 2017
    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 Primus Gloves Pvt Limited

    K Number Device Name
    K170612 STERILE VINYL EXAMINATION GLOVES, Powder Free
    K143477 Nitrile Patient Examination gloves, Powderfree, Blue color