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

    POWDERED VINYL EXAM GLOVES, WHITE

    K Number: K030927 · Decision Apr 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    8
    Review Days
    24

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    POWDERED VINYL EXAM GLOVES, WHITE
    K Number
    K030927
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Copioumed Intl., Inc.
    Date Received
    March 24, 2003
    Decision Date
    April 17, 2003
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LYZ), ordered by most recent decision date.

    Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Vinyl Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder-Free Vinyl Exam Gloves, clear

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Vinyl Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Vinyl examination gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Powder Free Vinyl Examination Gloves, Beige/Clear

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Copioumed Intl., Inc.

    K Number Device Name
    K021961 POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
    K021743 (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
    K972624 POLY (VINYL) EXAM GLOVE, POWDER-FREE
    K971316 POLY (VINYL) EXAM GLOVE, POWDERED
    K965237 NURSES BOUFFANT CAP
    K960999 ISOLATION GOWN
    K961342 SHOE COVER, NON-STERILE