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

    NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR

    K Number: K990453 · Decision Mar 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    12
    Review Days
    25

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    Basic Information

    Device Name
    NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
    K Number
    K990453
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alliance Rubber Products Sdn. Bhd.
    Date Received
    February 12, 1999
    Decision Date
    March 9, 1999
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Alliance Rubber Products Sdn. Bhd.

    K Number Device Name
    K002701 POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)
    K992870 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI
    K991981 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
    K990485 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
    K990486 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
    K990427 ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
    K983146 ARSOFT
    K980589 AR SAFE NITRILE EXAMINATION GLOVES
    K972801 ALLIANCE RUBBER, EC-GRIP
    K971183 GOLD FINGERS
    Search all 12 clearances from Alliance Rubber Products Sdn. Bhd. →