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

    Nitrile Patient Examination Powder Free Glove, Textured, Black

    K Number: K161085 · Decision Jul 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    808

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    Basic Information

    Device Name
    Nitrile Patient Examination Powder Free Glove, Textured, Black
    K Number
    K161085
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Multisafe Sdn. Bhd.
    Date Received
    April 18, 2016
    Decision Date
    July 5, 2018
    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 Multisafe Sdn. Bhd.

    K Number Device Name
    K062526 BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
    K062527 BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
    K011293 POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
    K001497 MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
    K001619 MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
    K000999 MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K993811 MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE