BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

    K Number: K172864 · Decision May 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    9
    Review Days
    224

    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
    Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    K Number
    K172864
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maxter Glove Manufacturing Sdn Bhd
    Date Received
    September 20, 2017
    Decision Date
    May 2, 2018
    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

    Other Clearances by Maxter Glove Manufacturing Sdn Bhd

    K Number Device Name
    K151390 Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
    K113100 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K040176 MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
    K032501 MAXTER STERILE POWDER FREE SURGICAL GLOVES
    K032467 MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
    K013554 POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K013498 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K013443 POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2