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

    LATEX SURGEONS GLOVE (POWDER FREE)

    K Number: K014283 · Decision May 22, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    146

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    Basic Information

    Device Name
    LATEX SURGEONS GLOVE (POWDER FREE)
    K Number
    K014283
    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
    Brightway Gloves Pvt. , Ltd.
    Date Received
    December 27, 2001
    Decision Date
    May 22, 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 Brightway Gloves Pvt. , Ltd.

    K Number Device Name
    K014278 LATEX SURGEONS GLOVE (POWDERED)
    K014280 LATEX EXAMINATION GLOVE (POWDERED)
    K014279 LATEX EXAMINATION GLOVES (POWDER FREE)