Search Results

Powder free 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)

Summary of Device Performance Study:

The provided text describes a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies for Class I devices like examination gloves. The "study" in this context refers to the nonclinical tests conducted to prove the device meets established standards and is comparable to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device