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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

The subject device is a patient examination glove made of synthetic nitrile latex compound. It is Non-Sterile, Powder free and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-11.

AI/ML Overview

The provided text describes Shandong Intco Medical Products Co, Ltd.'s Basic Synguard Nitrile Exam Gloves. This is a medical device submission, and the acceptance criteria and study described relate to the physical and biocompatibility performance of these gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimensions	ASTM D6319-19
Length	230 mm min	Pass (240 mm min)
Width	XS: 70±10, S: 80±10, M: 95±10, L: 110±10, XL: 120±10, XXL: 130±10	Pass (XS: avg 78.3mm, S: avg 86.5mm, M: avg 97.6mm, L: avg 108.7mm, XL: avg 115.4mm, XXL: avg 123.7mm)
Thickness	Palm: Minimum 0.05 mm, Finger: Minimum 0.05 mm	Pass (Palm 0.06mm min, Finger 0.082mm min)
Physical Properties	ASTM D6319-19
Before Aging
Tensile Strength	14 MPa, min	Pass (22.6 MPa, min)
Elongation	500%, min	Pass (531%, min)
After Aging
Tensile Strength	14 MPa, min	Pass (21.9 MPa, min)
Elongation	400%, min	Pass (437%, min)
Freedom from holes	ASTM D5151-19 (No leakage at sampling level of G-1, AQL 2.5)	Pass (No leakage, 312 of 315 gloves passed)
Residual Powder	ASTM D6124-06 (Reapproved 2017) (

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