BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POWDERED LATEX SURGEON'S GLOVE

    K Number: K052031 · Decision Sep 12, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    6
    Review Days
    47

    Basic Information

    Device Name
    POWDERED LATEX SURGEON'S GLOVE
    K Number
    K052031
    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
    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
    Date Received
    July 27, 2005
    Decision Date
    September 12, 2005
    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 SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

    K Number Device Name
    K092617 ROYAL GUARD
    K060229 POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE
    K052030 SURGEON'S GLOVE, POWDER FREE
    K040406 POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
    K040408 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)