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

    REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS

    K Number: K902601 · Decision Aug 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    59

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    Basic Information

    Device Name
    REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS
    K Number
    K902601
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Regent Hospital Products
    Date Received
    June 12, 1990
    Decision Date
    August 10, 1990
    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 Regent Hospital Products

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