BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)

    K Number: K051662 · Decision Jul 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    11
    Review Days
    30

    Basic Information

    Device Name
    VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
    K Number
    K051662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GRAND WORK PLASTIC PRODUCTS CO., LTD.
    Date Received
    June 22, 2005
    Decision Date
    July 22, 2005
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by GRAND WORK PLASTIC PRODUCTS CO., LTD.

    K Number Device Name
    K142409 Vinyl Co-Polymer Powder Free Examination Gloves
    K102089 GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    K102094 POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    K061562 VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
    K042830 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
    K040682 SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
    K041225 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
    K040681 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
    K041188 GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED
    K040702 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
    Search all 11 clearances from GRAND WORK PLASTIC PRODUCTS CO., LTD. →