Search Results

ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided document describes the FDA 510(k) summary for ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). This is a medical glove, which is a Class I device and does not involve AI/ML. Therefore, many of the typical questions regarding AI/ML device studies are not applicable.

Here's the information that can be extracted from the document based on your request:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device