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

    PATIENT NITRILE EXAMINATION GLOVES (POWDERED)

    K Number: K992675 · Decision Jan 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    163

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    Basic Information

    Device Name
    PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
    K Number
    K992675
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wear Safe Malaysia Sdn. Bhd.
    Date Received
    August 10, 1999
    Decision Date
    January 20, 2000
    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 Wear Safe Malaysia Sdn. Bhd.

    K Number Device Name
    K062917 STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
    K062778 STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
    K992681 PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
    K992676 PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
    K992678 PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
    K992679 SURGEON POWDER-FREE GLOVES, LATEX, STERILE
    K973020 PATIENT EXAMINATION POWDER-FREE GLOVES