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

    AMPRI

    K Number: K952833 · Decision Sep 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    77

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    Basic Information

    Device Name
    AMPRI
    K Number
    K952833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ampri Rubberware Industries Sdn Bhd
    Date Received
    June 20, 1995
    Decision Date
    September 5, 1995
    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 Ampri Rubberware Industries Sdn Bhd

    K Number Device Name
    K990677 ABSOGEL CHEMOTHERAPHY GLOVES
    K990812 POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA
    K954002 AMPRI
    K945948 ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES
    K946056 ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)
    K892176 CORRECT TOUCH SURGEONS GLOVES
    K892175 CORRECT TOUCH EXAMINATION GLOVES (LATEX)