BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    K Number: K964964 · Decision Feb 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    K Number
    K964964
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunmax Enterprise Shanghai Co. , Ltd.
    Date Received
    December 11, 1996
    Decision Date
    February 7, 1997
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by Sunmax Enterprise Shanghai Co. , Ltd.

    K Number Device Name
    K090336 SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
    K011765 SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
    K011717 SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
    K960746 SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES