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

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE

    K Number: K111772 · Decision Oct 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    19
    Review Days
    119

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    Basic Information

    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
    K Number
    K111772
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kossan Latex Industries(M)Sdn Bhd
    Date Received
    June 23, 2011
    Decision Date
    October 20, 2011
    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 Kossan Latex Industries(M)Sdn Bhd

    K Number Device Name
    K123749 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
    K120066 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
    K062764 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
    K062965 CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
    K060775 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
    K060771 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
    K024025 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
    K001557 LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
    K001190 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
    K992497 POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
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