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

    Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove

    K Number: K203236 · Decision Aug 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    3
    Review Days
    286

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    Basic Information

    Device Name
    Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
    K Number
    K203236
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rhino Health, Inc.
    Date Received
    November 3, 2020
    Decision Date
    August 16, 2021
    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 Rhino Health, Inc.

    K Number Device Name
    K223859 Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
    K221082 Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl