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

    PATIENT EXAMINATION GLOVES (LATEX)

    K Number: K891374 · Decision Jun 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    102

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVES (LATEX)
    K Number
    K891374
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    M.R.G. Industries Sdn. Bhd.
    Date Received
    March 9, 1989
    Decision Date
    June 19, 1989
    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 M.R.G. Industries Sdn. Bhd.

    K Number Device Name
    K991304 HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K991305 HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
    K981893 HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
    K941451 MRG POWDER FREE LATEX EXAMINATION GLOVES