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

    CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)

    K Number: K992358 · Decision Sep 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
    K Number
    K992358
    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
    July 14, 1999
    Decision Date
    September 10, 1999
    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 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
    K981333 NITRILON CORRECT-TOUCH