BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Annuy Latex Surgeon's Gloves (Powdered and Powder Free)

    K Number: K150609 · Decision Nov 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    2
    Review Days
    251

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    Basic Information

    Device Name
    Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
    K Number
    K150609
    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
    Anhui Anyu Latex Products Co., Ltd.
    Date Received
    March 10, 2015
    Decision Date
    November 16, 2015
    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 Anhui Anyu Latex Products Co., Ltd.

    K Number Device Name
    K150612 Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)