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

    NITRILE EXAMINATION GLOVES, POWDER FREE

    K Number: K051333 · Decision Jul 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    60

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    Basic Information

    Device Name
    NITRILE EXAMINATION GLOVES, POWDER FREE
    K Number
    K051333
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shun Thai Rubber Gloves Industry Co., Ltd.
    Date Received
    May 23, 2005
    Decision Date
    July 22, 2005
    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 Shun Thai Rubber Gloves Industry Co., Ltd.

    K Number Device Name
    K982416 SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
    K952695 BOSTON MEDICAL LATEX EXAM GLOVES
    K930139 HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES
    K892554 STERILE PATIENT EXAMINATION GLOVE
    K891300 NON-STERILE PATIENT EXAMINATION GLOVE