BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)

    K Number: K040792 · Decision Aug 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    12
    Review Days
    136

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    Basic Information

    Device Name
    POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
    K Number
    K040792
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pt. Smartglove Indonesia
    Date Received
    March 29, 2004
    Decision Date
    August 12, 2004
    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 Pt. Smartglove Indonesia

    K Number Device Name
    K133699 POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
    K101630 POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
    K101293 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
    K092034 POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
    K041848 POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
    K040791 POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
    K030284 POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
    K030406 NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
    K030112 POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB
    K022814 MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
    Search all 12 clearances from Pt. Smartglove Indonesia →