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

    Sterile Latex Surgical Glove, Powder Free

    K Number: K190241 · Decision Dec 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    8
    Review Days
    327

    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
    Sterile Latex Surgical Glove, Powder Free
    K Number
    K190241
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careglove Global Sdn. Bhd.
    Date Received
    February 6, 2019
    Decision Date
    December 30, 2019
    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 Careglove Global Sdn. Bhd.

    K Number Device Name
    K250578 Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
    K230121 Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
    K220859 Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
    K213993 Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
    K211666 Powder Free Nitrile Examination Gloves, Blue Chemotest
    K172015 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
    K161833 LATEX EXAMINATION GLOVE POWDER FREE