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

    Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs

    K Number: K171898 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    11
    Review Days
    53

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    Basic Information

    Device Name
    Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
    K Number
    K171898
    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
    Better Care Plastic Technology Co., Ltd.
    Date Received
    June 26, 2017
    Decision Date
    August 18, 2017
    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 Better Care Plastic Technology Co., Ltd.

    K Number Device Name
    K242533 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K232070 Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
    K231567 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
    K223713 Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K222449 Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
    K221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K182600 Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
    K171047 Sterile Polyisoprene Powder Free Surgical Gloves
    K140816 POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
    Search all 11 clearances from Better Care Plastic Technology Co., Ltd. →