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

    LATEX EXAMINATION GLOVES

    K Number: K891065 · Decision Mar 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    15

    Basic Information

    Device Name
    LATEX EXAMINATION GLOVES
    K Number
    K891065
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    MODERN RUBBER INDUSTRIAL CO., LTD.
    Date Received
    March 1, 1989
    Decision Date
    March 16, 1989
    Product Code
    LYY
    Advisory Committee
    General Hospital
    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
    LYY Latex Patient Examination Glove

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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
    K892064 LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN