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

    NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)

    K Number: K991779 · Decision Aug 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    78

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    Basic Information

    Device Name
    NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
    K Number
    K991779
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Seltom Pacific Sdn. Bhd.
    Date Received
    May 25, 1999
    Decision Date
    August 11, 1999
    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 Seltom Pacific Sdn. Bhd.

    K Number Device Name
    K011924 POWDERED BLUE NITRILE EXAMINATION GLOVES
    K011922 POWDERED LATEX EXAMINATION GLOVES
    K003934 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    K991777 LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)
    K991778 LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
    K991776 NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)