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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
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter for "BIOTECH Nitrile Examination Gloves." This document confirms the substantial equivalence of the gloves to previously marketed devices and outlines regulatory requirements.

    It does NOT contain any information about acceptance criteria, device performance testing, study design (sample size, data provenance), expert involvement, ground truth establishment, or any details related to an AI-powered medical device.

    Therefore, I cannot extract the information required to answer your request. The product in question is a physical medical device (examination gloves), not an AI-based system.

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