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

    JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)

    K Number: K222349 · Decision Oct 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    8
    Review Days
    79

    Basic Information

    Device Name
    JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
    K Number
    K222349
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    JR Engineering & Medical Technologies (M) SDN.BHD.
    Date Received
    August 3, 2022
    Decision Date
    October 21, 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 JR Engineering & Medical Technologies (M) SDN.BHD.

    K Number Device Name
    K222348 JR MEDIC
    K221169 JR MEDIC Nitrile Examination Gloves Powder Free- Black
    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