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

    MULTIPLE

    K Number: K945164 · Decision Feb 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    105

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    Basic Information

    Device Name
    MULTIPLE
    K Number
    K945164
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Protection Gloves Sdn. Bhd.
    Date Received
    October 21, 1994
    Decision Date
    February 3, 1995
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Protection Gloves Sdn. Bhd.

    K Number Device Name
    K010854 CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
    K011231 CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
    K000668 POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA
    K000667 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM