BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Latex Examination Gloves, Powder Free

    K Number: K213509 · Decision Apr 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    157

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    Basic Information

    Device Name
    Latex Examination Gloves, Powder Free
    K Number
    K213509
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Intco Medical Products Co, Ltd.
    Date Received
    November 2, 2021
    Decision Date
    April 8, 2022
    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 Shandong Intco Medical Products Co, Ltd.

    K Number Device Name
    K233042 Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K231408 Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
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