LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202419
    Device Name
    BIOTECH Nitrile Examination Gloves
    Manufacturer
    TK Hitech Technology Co., Ltd.
    Date Cleared
    2021-04-16

    (235 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    TK Hitech Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BIOTECH Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    BIOTECH Nitrile Examination Gloves
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1