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

    Sterile Latex Surgical Gloves, Powder Free

    K Number: K171550 · Decision Jul 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    413

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    Basic Information

    Device Name
    Sterile Latex Surgical Gloves, Powder Free
    K Number
    K171550
    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
    Sanrea Healthcare Products Pvt, Ltd.
    Date Received
    May 26, 2017
    Decision Date
    July 13, 2018
    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 Sanrea Healthcare Products Pvt, Ltd.

    K Number Device Name
    K171367 SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
    K171093 STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE