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

    HI-TOUCH (TM) BRAND SURGICAL GLOVES

    K Number: K874539 · Decision Dec 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    8
    Review Days
    41

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    Basic Information

    Device Name
    HI-TOUCH (TM) BRAND SURGICAL GLOVES
    K Number
    K874539
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Apex Medical Technologies, Inc.
    Date Received
    November 3, 1987
    Decision Date
    December 14, 1987
    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 Apex Medical Technologies, Inc.

    K Number Device Name
    K112165 RHEA CUP
    K060933 SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
    K954791 SEMINAL FLUID COLLECTION KIT II
    K922688 EXTRA PROTECTION POLYURETHANE CONDOM
    K930313 APEX SPECIMEN BAG
    K902936 POLYURETHANE CONDOM
    K871358 SENSATIONS BRAND CONDOMS