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510(k) Data Aggregation
(52 days)
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)
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)":
This document describes a 510(k) premarket notification for a medical device -- Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The studies conducted are non-clinical, primarily focused on meeting established material and performance standards for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
---|---|---|
Dimension | ASTM standard D 5250-06 | Meets |
Physical Properties | ASTM standard D 5250-06 | Meets |
Freedom from pinholes | 21-CFR 800.20 | Meets |
Powder Residual | ASTM standard D 5250-06 and D6124-06 | Meets ( |
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