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

    Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

    K Number: K250069 · Decision Apr 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    109

    Basic Information

    Device Name
    Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
    K Number
    K250069
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Received
    January 10, 2025
    Decision Date
    April 29, 2025
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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