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

    TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES

    K Number: K021950 · Decision Aug 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    49

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    Basic Information

    Device Name
    TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
    K Number
    K021950
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Top Glove Medical (Thailand) Co., Ltd.
    Date Received
    June 13, 2002
    Decision Date
    August 1, 2002
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Top Glove Medical (Thailand) Co., Ltd.

    K Number Device Name
    K222129 Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
    K022016 POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE