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

    BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE

    K Number: K073299 · Decision Mar 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    103

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    Basic Information

    Device Name
    BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
    K Number
    K073299
    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
    November 23, 2007
    Decision Date
    March 5, 2008
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Betel Care Sdn. Bhd.

    K Number Device Name
    K222342 Betel Gloves Nitrile Examination Glove 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)