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

    POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR

    K Number: K060785 · Decision Jul 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    11
    Review Days
    107

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    Basic Information

    Device Name
    POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR
    K Number
    K060785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ever Light Plastic Products Co., Ltd.
    Date Received
    March 22, 2006
    Decision Date
    July 7, 2006
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by Ever Light Plastic Products Co., Ltd.

    K Number Device Name
    K142570 Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
    K142571 Powder Free Vinyl Patient Examination Gloves
    K102655 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE)
    K082029 SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
    K063215 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    K063214 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
    K063213 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
    K060786 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
    K060784 SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
    K060778 SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
    Search all 11 clearances from Ever Light Plastic Products Co., Ltd. →