FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM standard D 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from Pinhole	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-06