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

    DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

    K Number: K032236 · Decision Aug 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    4
    Review Days
    36

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    Basic Information

    Device Name
    DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
    K Number
    K032236
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Est International Corporation
    Date Received
    July 21, 2003
    Decision Date
    August 26, 2003
    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 Est International Corporation

    K Number Device Name
    K040108 OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
    K041325 DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE
    K032272 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR