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

    Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove

    K Number: K200633 · Decision Oct 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    1
    Review Days
    215

    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
    Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
    K Number
    K200633
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    0 & M Halyard, Inc.
    Date Received
    March 10, 2020
    Decision Date
    October 11, 2020
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

    Similar 510(k) Clearances

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

    Cardinal Health Nitrile Examination Gloves Extended Cuff

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    JR Medic

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

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