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

    SBG Blue Nitrile Powder Free Medical Examination Glove

    K Number: K180467 · Decision Oct 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    231

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    Basic Information

    Device Name
    SBG Blue Nitrile Powder Free Medical Examination Glove
    K Number
    K180467
    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
    February 21, 2018
    Decision Date
    October 10, 2018
    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 Showa Best Glove, Inc.

    K Number Device Name
    K211003 SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
    K190159 Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
    K180468 SBG Black Nitrile Powder Free Medical Examination Glove