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

    REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES

    K Number: K891658 · Decision Jun 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    78

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    Basic Information

    Device Name
    REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES
    K Number
    K891658
    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
    March 20, 1989
    Decision Date
    June 6, 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 Regent Hospital Products

    K Number Device Name
    K951908 REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE
    K910928 RUBBER LATEX SURGEONS GLOVES
    K902601 REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS
    K896432 RUBBER LATEX SURGEON'S GLOVE