BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NITRILON CORRECT-TOUCH

    K Number: K981333 · Decision Jun 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    NITRILON CORRECT-TOUCH
    K Number
    K981333
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biopro (M) Sdn Bhd
    Date Received
    April 13, 1998
    Decision Date
    June 22, 1998
    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 Biopro (M) Sdn Bhd

    K Number Device Name
    K994281 BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)
    K994276 BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)
    K994043 CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
    K992358 CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)