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510(k) Data Aggregation
(89 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided document is a 510(k) summary for a medical device: "Disposable Vinyl Nitrile Synthetic Gloves Powder Free". This document describes the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length (mm): ≥230 | |
| Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | |||
| Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: >230 | ||
| Width: S: 84-89; M: 93-97; L: 105-107; XL: 115-116 | |||
| Finger Thickness: 0.08-0.2 | |||
| Palm Thickness: 0.07-0.08 | |||
| Result: Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks |
| Result: Pass | |||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
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