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

    LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN

    K Number: K892064 · Decision Apr 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    27

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    Basic Information

    Device Name
    LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN
    K Number
    K892064
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Modern Rubber Industrial Co., Ltd.
    Date Received
    March 30, 1989
    Decision Date
    April 26, 1989
    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 Modern Rubber Industrial Co., Ltd.

    K Number Device Name
    K900669 HYPO-ALLERGENIC SURGICAL GLOVES
    K893492 LATEX EXAMINATION GLOVES
    K892056 SURGICAL LATEX STERILE GLOVES
    K891065 LATEX EXAMINATION GLOVES