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

    LATEX EXAMINATION GLOVES

    K Number: K891445 · Decision Aug 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    14
    Review Days
    147

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVES
    K Number
    K891445
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Superior Healthcare Group, Inc.
    Date Received
    March 15, 1989
    Decision Date
    August 9, 1989
    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 Superior Healthcare Group, Inc.

    K Number Device Name
    K925530 INSTRUMENT WARMER
    K924764 OVERTUBE FOR ENDSCOPIC LIGATOR
    K905755 NON-STERILE PATIENT EXAMINATION GLOVES
    K903347 SODIUM CHLORIDE SOLUTION
    K904216 STERILE WATER SOLUTION CATALOG # 10000
    K903340 STERILE URETHRAL CATHETER PROCEDURE KITS
    K896321 NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
    K894676 STERILE LATEX EXAM GLOVES
    K892426 NO. 86500 - ENDOSCOPIC JET WASHER
    K885339 FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
    Search all 14 clearances from Superior Healthcare Group, Inc. →