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

    POWDER FREE NITRILE EXAMINATION GLOVE

    K Number: K011012 · Decision May 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    27

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    Basic Information

    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE
    K Number
    K011012
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Contract Latex Dippers Sdn Bhd
    Date Received
    April 4, 2001
    Decision Date
    May 1, 2001
    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 Contract Latex Dippers Sdn Bhd

    K Number Device Name
    K983568 OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
    K955947 OSTAR EXAMINATION GLOVES
    K954063 GLOVE SEAL & SET-RITE
    K934316 GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES