BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇭 Thailand

    HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

    K Number: K162381 · Decision Jan 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    160

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    Basic Information

    Device Name
    HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
    K Number
    K162381
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healthy Glove Co., Ltd.
    Date Received
    August 24, 2016
    Decision Date
    January 31, 2017
    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 Healthy Glove Co., Ltd.

    K Number Device Name
    K152479 HG Pro Nitrile Powder Free Examination Gloves