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

    CIR LATEX GLOVES (CIR GOLD SEAL)

    K Number: K935980 · Decision May 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    140

    Basic Information

    Device Name
    CIR LATEX GLOVES (CIR GOLD SEAL)
    K Number
    K935980
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CROCKER INDUSTRIAL RESOURCES SDN. BHD.
    Date Received
    December 13, 1993
    Decision Date
    May 2, 1994
    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 CROCKER INDUSTRIAL RESOURCES SDN. BHD.

    K Number Device Name
    K980754 CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G
    K960842 LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)
    K943858 POWDER FREE (SILICONIZED) EXAM GLOVES
    K924419 CIR LATEX GLOVES
    K892465 NON-STERILE PATIENT EXAMINATION GLOVES