BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    GLOVES, PATIENT EXAMINATION

    K Number: K890344 · Decision Apr 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    327
    Applicant Total
    5
    Review Days
    93

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    Basic Information

    Device Name
    GLOVES, PATIENT EXAMINATION
    K Number
    K890344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Tomarc (M) Sdn Bhd
    Date Received
    January 23, 1989
    Decision Date
    April 26, 1989
    Product Code
    JTN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTN Susceptibility Test Discs, Antimicrobial

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    Other Clearances by Tomarc (M) Sdn Bhd

    K Number Device Name
    K931633 POWDER-FREE LATEX PATIENT EXAMINATION GLOVES
    K923589 STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV
    K892899 STERILE LATEX SURGICAL GLOVE
    K890440 LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)