BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)

    K Number: K960842 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    386

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    Basic Information

    Device Name
    LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)
    K Number
    K960842
    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
    February 27, 1996
    Decision Date
    March 19, 1997
    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
    K943858 POWDER FREE (SILICONIZED) EXAM GLOVES
    K935980 CIR LATEX GLOVES (CIR GOLD SEAL)
    K924419 CIR LATEX GLOVES
    K892465 NON-STERILE PATIENT EXAMINATION GLOVES