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

    Sterile Nitrile Surgical Gloves Powder Free

    K Number: K222350 · Decision Apr 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    10
    Review Days
    253

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    Basic Information

    Device Name
    Sterile Nitrile Surgical Gloves Powder Free
    K Number
    K222350
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jr Engineering & Medical Technologies (M) Sdn. Bhd.
    Date Received
    August 3, 2022
    Decision Date
    April 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 Jr Engineering & Medical Technologies (M) Sdn. Bhd.

    K Number Device Name
    K221626 Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
    K222348 JR MEDIC
    K221169 JR MEDIC Nitrile Examination Gloves Powder Free- Black
    K222349 JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
    K221157 JR Medic
    K212827 Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
    K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Free
    K192333 Blue Nitrile Examination Gloves Powder Free
    K192329 Blue Latex Examination Powder Free Gloves