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

    NON-STERILE PATIENT EXAMINATION GLOVES

    K Number: K892465 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    98

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    Basic Information

    Device Name
    NON-STERILE PATIENT EXAMINATION GLOVES
    K Number
    K892465
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Crocker Industrial Resources Sdn. Bhd.
    Date Received
    April 7, 1989
    Decision Date
    July 14, 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 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
    K935980 CIR LATEX GLOVES (CIR GOLD SEAL)
    K924419 CIR LATEX GLOVES