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

    POWDERFREE LATEX SURGEON'S GLOVES

    K Number: K013914 · Decision Feb 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    POWDERFREE LATEX SURGEON'S GLOVES
    K Number
    K013914
    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
    Kanam Latex Industries Pvt. , Ltd.
    Date Received
    November 27, 2001
    Decision Date
    February 6, 2002
    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 Kanam Latex Industries Pvt. , Ltd.

    K Number Device Name
    K052214 PRE-POWDERED STERILE EXAM GLOVES
    K033564 POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2
    K904972 SURGICARE STERILE SURGICAL GLOVES
    K897139 LATEX PATIENT EXAMINATION GLOVES