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

    Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid

    K Number: K202416 · Decision Nov 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    98

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    Basic Information

    Device Name
    Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
    K Number
    K202416
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly Clark Corporation
    Date Received
    August 24, 2020
    Decision Date
    November 30, 2020
    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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