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

    VINYL PATIENT EXAMINATION GLOVE, POWDERED

    K Number: K981360 · Decision Oct 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    6
    Review Days
    184

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    Basic Information

    Device Name
    VINYL PATIENT EXAMINATION GLOVE, POWDERED
    K Number
    K981360
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glormed Intl., Inc.
    Date Received
    April 14, 1998
    Decision Date
    October 15, 1998
    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 Glormed Intl., Inc.

    K Number Device Name
    K041945 POWDER-FREE BLUE VINYL EXAM GLOVES
    K031104 POWDERED VINYL EXAM GLOVES, WHITE
    K021353 POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
    K002340 VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
    K983494 VINYL EXAM GLOVES, POWDER FREE