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

    (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW

    K Number: K021743 · Decision Jun 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    13

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    Basic Information

    Device Name
    (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
    K Number
    K021743
    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
    May 28, 2002
    Decision Date
    June 10, 2002
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Copioumed Intl., Inc.

    K Number Device Name
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    K972624 POLY (VINYL) EXAM GLOVE, POWDER-FREE
    K971316 POLY (VINYL) EXAM GLOVE, POWDERED
    K965237 NURSES BOUFFANT CAP
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