BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves

    K Number: K220118 · Decision May 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    3
    Review Days
    118

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    Basic Information

    Device Name
    Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
    K Number
    K220118
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kl-Kepong Rubber Products Sdn. Bhd.
    Date Received
    January 14, 2022
    Decision Date
    May 12, 2022
    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 Kl-Kepong Rubber Products Sdn. Bhd.

    K Number Device Name
    K243133 Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
    K023866 POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES