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

    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs

    K Number: K201748 · Decision Oct 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    61
    Review Days
    98

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    Basic Information

    Device Name
    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
    K Number
    K201748
    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
    Hartalega Sdn Bhd
    Date Received
    June 26, 2020
    Decision Date
    October 2, 2020
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Hartalega Sdn Bhd

    K Number Device Name
    K201531 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
    K200897 Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
    K180645 Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
    K180786 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
    K173509 Biodegradable Nitrile Powder Free Examination Glove (Blue)
    K180644 Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
    K180505 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
    K173137 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
    K171874 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
    K170152 POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
    Search all 61 clearances from Hartalega Sdn Bhd →