BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Vinyl compound examination gloves

    K Number: K211229 · Decision Jul 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    7
    Review Days
    97

    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
    Vinyl compound examination gloves
    K Number
    K211229
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hebei Titans Hongsen Medical Technology Co., Ltd.
    Date Received
    April 23, 2021
    Decision Date
    July 29, 2021
    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 Hebei Titans Hongsen Medical Technology Co., Ltd.

    K Number Device Name
    K240361 Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)
    K223895 Disposable Medical Nitrile Examination Gloves
    K221374 Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
    K212097 Disposable medical surgical mask
    K182043 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
    K181130 Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs