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

    Medical nitrile examination gloves (Model: SH001)

    K Number: K213600 · Decision Feb 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    96

    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
    Medical nitrile examination gloves (Model: SH001)
    K Number
    K213600
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangxi Sanhao Medical Instruments Co.,Ltd
    Date Received
    November 15, 2021
    Decision Date
    February 19, 2022
    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.

    Powder Free Nitrile Examination Gloves Non-Sterile Black

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Nitrile Disposable Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Syntex Exam Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

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

    Other Clearances by Jiangxi Sanhao Medical Instruments Co.,Ltd

    K Number Device Name
    K221173 Surgical Mask (Model: 0868F, 0866F)