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

    LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)

    K Number: K890440 · Decision May 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    105

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    Basic Information

    Device Name
    LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)
    K Number
    K890440
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tomarc (M) Sdn Bhd
    Date Received
    January 27, 1989
    Decision Date
    May 12, 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 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
    K890344 GLOVES, PATIENT EXAMINATION