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

    BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC

    K Number: K904232 · Decision Sep 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    9

    Basic Information

    Device Name
    BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
    K Number
    K904232
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    BOSTON MEDICAL CORP.
    Date Received
    September 12, 1990
    Decision Date
    September 21, 1990
    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 BOSTON MEDICAL CORP.

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    K923385 BOSTON BRAND HYPOALLERGENIC LATEX GLOVES
    K911146 TAN CHONG GLOVE, HYPOALLERGENIC
    K910660 BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
    K891103 STERILE PATIENT EXAMINATION GLOVE
    K890538 GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES