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

    OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER

    K Number: K983568 · Decision Dec 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    69

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    Basic Information

    Device Name
    OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
    K Number
    K983568
    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
    October 13, 1998
    Decision Date
    December 21, 1998
    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 Contract Latex Dippers Sdn Bhd

    K Number Device Name
    K011012 POWDER FREE NITRILE EXAMINATION GLOVE
    K955947 OSTAR EXAMINATION GLOVES
    K954063 GLOVE SEAL & SET-RITE
    K934316 GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES