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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.

Device Description

The subject device is powder free vinyl patient examination gloves. During the production process, about 1% ~ 3% nitrile is added to the ingrove the tensile strength and ultimate elongation of the glove. 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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Disposable Synthetic Vinyl Nitrile Examination Glove). It outlines acceptance criteria and test results for various non-clinical tests. Since the device is not an AI/ML powered device, the questions related to AI/ML powered devices are not applicable.

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): $\ge$ 230;
Width(mm):
XS: 75 ± 5;
S: 85 ± 5;
M: 95 ± 5;
L: 105 ± 5;
XL: 115 ± 5;
Thickness (mm):
Finger: $\ge$ 0.08
Palm: $\ge$ 0.08	Length: >230/ Pass
Width:
XS: 78-80/ Pass
S: 85-86/Pass
M: 95-96/Pass
L: 105-106/Pass
XL: 115-116/Pass
Finger Thickness:
XS: 0.11-0.12/Pass
S:0.11-0.12/Pass
M:0.11-0.13/Pass
L:0.11-0.13/Pass
XL:0.11-0.13/Pass
Palm Thickness:
XS:0.08-0.09/Pass
S:0.08-0.09/Pass
M:0.08-0.09/Pass
L:0.08-0.09/Pass
XL:0.08-0.09/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL=2.5	XS:0/125;S:1/125;M:3/125; L:2/125;XL:2/125 leaks / Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124

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