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

    Powder Free Chloroprene Examination Glove Coloured (Blue, Green)

    K Number: K213993 · Decision Aug 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    227

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    Basic Information

    Device Name
    Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
    K Number
    K213993
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careglove Global Sdn. Bhd.
    Date Received
    December 21, 2021
    Decision Date
    August 5, 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 Careglove Global Sdn. Bhd.

    K Number Device Name
    K250578 Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
    K230121 Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
    K220859 Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
    K211666 Powder Free Nitrile Examination Gloves, Blue Chemotest
    K190241 Sterile Latex Surgical Glove, Powder Free
    K172015 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
    K161833 LATEX EXAMINATION GLOVE POWDER FREE