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

    Betel Gloves Nitrile Examination Glove Powder Free

    K Number: K222342 · Decision Sep 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    52

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    Basic Information

    Device Name
    Betel Gloves Nitrile Examination Glove Powder Free
    K Number
    K222342
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Betel Care Sdn. Bhd.
    Date Received
    August 3, 2022
    Decision Date
    September 24, 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 Betel Care Sdn. Bhd.

    K Number Device Name
    K073299 BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
    K000650 BETEL POWDER FREE LATEX EXAM GLOVES
    K000652 BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)