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

    Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove

    K Number: K190159 · Decision May 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    4
    Review Days
    96

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    Basic Information

    Device Name
    Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
    K Number
    K190159
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Showa Best Glove, Inc.
    Date Received
    January 30, 2019
    Decision Date
    May 6, 2019
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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    Other Clearances by Showa Best Glove, Inc.

    K Number Device Name
    K211003 SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
    K180467 SBG Blue Nitrile Powder Free Medical Examination Glove
    K180468 SBG Black Nitrile Powder Free Medical Examination Glove