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

    Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs

    K Number: K222892 · Decision Dec 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    19
    Review Days
    83

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    Basic Information

    Device Name
    Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
    K Number
    K222892
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grand Work Plastic Products Co., Ltd.
    Date Received
    September 23, 2022
    Decision Date
    December 15, 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 Grand Work Plastic Products Co., Ltd.

    K Number Device Name
    K232444 Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
    K232039 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K230217 Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
    K213574 Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
    K220249 Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
    K220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
    K220240 Vinyl Co-Polymer Powder-free Examination Gloves, Black
    K142409 Vinyl Co-Polymer Powder Free Examination Gloves
    K102089 GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    K102094 POWDER FREE VINYL PATIENT EXAMINATION GLOVES
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