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

    POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM

    K Number: K960841 · Decision Aug 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    170

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    Basic Information

    Device Name
    POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
    K Number
    K960841
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Medical Corp.
    Date Received
    February 27, 1996
    Decision Date
    August 15, 1996
    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.

    K Number Device Name
    K981947 STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)
    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