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

    STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)

    K Number: K981947 · Decision Mar 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    8
    Review Days
    273

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    Basic Information

    Device Name
    STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)
    K Number
    K981947
    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
    Boston Medical Corp.
    Date Received
    June 3, 1998
    Decision Date
    March 3, 1999
    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 Boston Medical Corp.

    K Number Device Name
    K960841 POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
    K923385 BOSTON BRAND HYPOALLERGENIC LATEX GLOVES
    K911146 TAN CHONG GLOVE, HYPOALLERGENIC
    K910660 BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
    K904232 BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
    K891103 STERILE PATIENT EXAMINATION GLOVE
    K890538 GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES