BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    K Number: K203030 · Decision Jun 11, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    46
    Review Days
    252

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    Basic Information

    Device Name
    POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K Number
    K203030
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wrp Asia Pacific Sdn. Bhd.
    Date Received
    October 2, 2020
    Decision Date
    June 11, 2021
    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 Wrp Asia Pacific Sdn. Bhd.

    K Number Device Name
    K232079 Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
    K232538 DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
    K230578 Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
    K222058 Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
    K211601 Powder Free Latex Examination Glove, Non-Sterile
    K210330 Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
    K192635 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
    K161823 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
    K161422 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K141982 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Search all 46 clearances from Wrp Asia Pacific Sdn. Bhd. →