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

    Nitrile examination gloves

    K Number: K211927 · Decision Oct 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    4
    Review Days
    112

    Basic Information

    Device Name
    Nitrile examination gloves
    K Number
    K211927
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fitone Latex Products Co., Ltd. Guangdong
    Date Received
    June 22, 2021
    Decision Date
    October 12, 2021
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

    Similar 510(k) Clearances

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

    Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue

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

    Other Clearances by Fitone Latex Products Co., Ltd. Guangdong

    K Number Device Name
    K231446 Single-Use Latex Sterile Surgical Gloves (SG100)
    K221747 Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
    K222693 Single-use medical latex examination gloves (LG100)