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

    Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

    K Number: K211604 · Decision Oct 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    155

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    Basic Information

    Device Name
    Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
    K Number
    K211604
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanxi Hongjin Plastic Technology Co., Ltd.
    Date Received
    May 25, 2021
    Decision Date
    October 27, 2021
    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 Shanxi Hongjin Plastic Technology Co., Ltd.

    K Number Device Name
    K232550 Nitrile Examination Gloves, Dual Color Black-Blue
    K232353 Powder Free Nitrile Examination Gloves (Black)
    K230779 Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K220229 Powder Free Nitrile Examination Gloves, Orange
    K180381 Powder Free Vinyl Patient Examination Gloves
    K180260 Powder Free Vinyl Patient Examination Gloves (Yellow, White)