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

    MAXTER STERILE POWDER FREE SURGICAL GLOVES

    K Number: K032501 · Decision Oct 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    9
    Review Days
    65

    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
    MAXTER STERILE POWDER FREE SURGICAL GLOVES
    K Number
    K032501
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Maxter Glove Manufacturing Sdn Bhd
    Date Received
    August 13, 2003
    Decision Date
    October 17, 2003
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

    Similar 510(k) Clearances

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

    Sterile Latex Powder Free Surgical Gloves

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Polyisoprene Surgical gloves

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Maxter Glove Manufacturing Sdn Bhd

    K Number Device Name
    K172864 Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    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
    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