BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE

    K Number: K100977 · Decision Aug 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    4
    Review Days
    126

    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
    PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
    K Number
    K100977
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jiangsu Sunshine Plastic Products, Co., Ltd.
    Date Received
    April 8, 2010
    Decision Date
    August 12, 2010
    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 Jiangsu Sunshine Plastic Products, Co., Ltd.

    K Number Device Name
    K100975 NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
    K100978 POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
    K100979 NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE