Search Results

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (S"), medium (M"), large (L"), X-large (XL") for optional. The gloves are provided with blue color. The examination glove is smooth surface and a rolled rim at the cuff edge. The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.

This document is a 510(k) summary for a medical device (ZinRom powder-free nitrile examination gloves), not an AI/ML medical device. Therefore, the requested information (acceptance criteria and study details for an AI/ML device) is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physical properties and biocompatibility for a physical product (gloves). It explicitly states "No clinical study is included in this submission."

Consequently, I cannot provide a table of acceptance criteria and reported device performance for an AI/ML device, nor details about sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML.

Ask a specific question about this device