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

    POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED

    K Number: K032374 · Decision Oct 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    30
    Review Days
    82

    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
    POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
    K Number
    K032374
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Perusahaan Getah Asas Sdn. Bhd.
    Date Received
    August 1, 2003
    Decision Date
    October 22, 2003
    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 Perusahaan Getah Asas Sdn. Bhd.

    K Number Device Name
    K102790 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
    K042805 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
    K031625 POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
    K031768 BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
    K031414 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
    K031591 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
    K031021 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
    K030333 LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
    K030331 ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
    K030335 ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
    Search all 30 clearances from Perusahaan Getah Asas Sdn. Bhd. →