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

    BOSTON MEDICAL LATEX EXAM GLOVES

    K Number: K952695 · Decision Aug 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    BOSTON MEDICAL LATEX EXAM GLOVES
    K Number
    K952695
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shun Thai Rubber Gloves Industry Co., Ltd.
    Date Received
    June 14, 1995
    Decision Date
    August 11, 1995
    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 Shun Thai Rubber Gloves Industry Co., Ltd.

    K Number Device Name
    K051333 NITRILE EXAMINATION GLOVES, POWDER FREE
    K982416 SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
    K930139 HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES
    K892554 STERILE PATIENT EXAMINATION GLOVE
    K891300 NON-STERILE PATIENT EXAMINATION GLOVE