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

    DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES

    K Number: K935869 · Decision Feb 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    632
    Review Days
    83

    Basic Information

    Device Name
    DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES
    K Number
    K935869
    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
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Received
    December 3, 1993
    Decision Date
    February 24, 1994
    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.

    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

    PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove

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

    Single-Use Latex Sterile Surgical Gloves (SG100)

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

    Other Clearances by BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC →