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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs

    K Number: K142190 · Decision Jul 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    19
    Review Days
    340

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    Basic Information

    Device Name
    Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs
    K Number
    K142190
    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
    Pt. Medisafe Technologies
    Date Received
    August 8, 2014
    Decision Date
    July 14, 2015
    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

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    Other Clearances by Pt. Medisafe Technologies

    K Number Device Name
    K201774 Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
    K182176 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
    K173258 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
    K163041 Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
    K142941 Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
    K133689 POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
    K112654 POWDERFREE POLYISOPRENE SURGICAL GLOVES
    K102623 BLUE POWDERFREE NITRILE EXAMINATION GLOVE
    K102620 POWDERFREE BLACK NITRILE EXAMINATION GLOVES
    K082302 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
    Search all 19 clearances from Pt. Medisafe Technologies →