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

    REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE

    K Number: K951908 · Decision Sep 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    130

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    Basic Information

    Device Name
    REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE
    K Number
    K951908
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Regent Hospital Products
    Date Received
    April 24, 1995
    Decision Date
    September 1, 1995
    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 Regent Hospital Products

    K Number Device Name
    K910928 RUBBER LATEX SURGEONS GLOVES
    K902601 REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS
    K896432 RUBBER LATEX SURGEON'S GLOVE
    K891658 REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES