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

    Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

    K Number: K233560 · Decision Feb 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    15
    Review Days
    112

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    Basic Information

    Device Name
    Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
    K Number
    K233560
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eco Medi Glove Sdn. Bhd.
    Date Received
    November 6, 2023
    Decision Date
    February 26, 2024
    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 Eco Medi Glove Sdn. Bhd.

    K Number Device Name
    K232764 Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K233405 Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
    K220943 Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
    K202401 Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
    K193121 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
    K181066 Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
    K171339 EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
    K161187 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
    K161320 EMG Pink Nitrile Examination Glove Powder Free
    K152937 EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
    Search all 15 clearances from Eco Medi Glove Sdn. Bhd. →