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

    SURGEON POWDER-FREE GLOVES, LATEX, STERILE

    K Number: K992679 · Decision Oct 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    SURGEON POWDER-FREE GLOVES, LATEX, STERILE
    K Number
    K992679
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wear Safe Malaysia Sdn. Bhd.
    Date Received
    August 10, 1999
    Decision Date
    October 21, 1999
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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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
    K992675 PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
    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
    K973020 PATIENT EXAMINATION POWDER-FREE GLOVES