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

    N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

    K Number: K992170 · Decision Sep 7, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    71

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    Basic Information

    Device Name
    N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
    K Number
    K992170
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Best Manufacturing Company
    Date Received
    June 28, 1999
    Decision Date
    September 7, 1999
    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 Best Manufacturing Company

    K Number Device Name
    K022024 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
    K012899 GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
    K012166 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
    K001375 ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
    K993805 NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)