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

    POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

    K Number: K021961 · Decision Jul 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    8
    Review Days
    18

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    Basic Information

    Device Name
    POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
    K Number
    K021961
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Copioumed Intl., Inc.
    Date Received
    June 14, 2002
    Decision Date
    July 2, 2002
    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 Copioumed Intl., Inc.

    K Number Device Name
    K030927 POWDERED VINYL EXAM GLOVES, WHITE
    K021743 (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
    K972624 POLY (VINYL) EXAM GLOVE, POWDER-FREE
    K971316 POLY (VINYL) EXAM GLOVE, POWDERED
    K965237 NURSES BOUFFANT CAP
    K960999 ISOLATION GOWN
    K961342 SHOE COVER, NON-STERILE