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

    Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

    K Number: K230217 · Decision May 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    19
    Review Days
    107

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    Basic Information

    Device Name
    Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
    K Number
    K230217
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grand Work Plastic Products Co., Ltd.
    Date Received
    January 26, 2023
    Decision Date
    May 13, 2023
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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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
    K222892 Powder Free Polyurethane Examination Gloves, Blue color, 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
    Search all 19 clearances from Grand Work Plastic Products Co., Ltd. →