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

    NITRILE POWDERFREE EXAMINATION GLOVES

    K Number: K981877 · Decision Aug 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    22
    Review Days
    75

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    Basic Information

    Device Name
    NITRILE POWDERFREE EXAMINATION GLOVES
    K Number
    K981877
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Besglove Medicare Sdn. Bhd.
    Date Received
    May 28, 1998
    Decision Date
    August 11, 1998
    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 Besglove Medicare Sdn. Bhd.

    K Number Device Name
    K994082 POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
    K993500 POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
    K993495 POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
    K993502 POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
    K981878 POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
    K981879 POWDERED NITRILE EXAMINATION GLOVES
    K982286 POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
    K982285 POWDERFREE GREEN LATEX EXAMINATION GLOVES
    K982284 POWDERED GREEN LATEX EXAMINATION GLOVES
    K981673 POWDERFREE GREEN NITRILE EXAMINATION GLOVES
    Search all 22 clearances from Besglove Medicare Sdn. Bhd. →