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

    STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV

    K Number: K923589 · Decision Jul 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    368

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    Basic Information

    Device Name
    STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV
    K Number
    K923589
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tomarc (M) Sdn Bhd
    Date Received
    July 20, 1992
    Decision Date
    July 23, 1993
    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
    K892899 STERILE LATEX SURGICAL GLOVE
    K890440 LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)
    K890344 GLOVES, PATIENT EXAMINATION