Search Results

Powdered vinyl patient examination glove 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

The document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device