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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.

powdered vinyl patient examination gloves, white(non-colored) that mects all of the requirements of ASTM standard D 5250-0004.

1. Table of Acceptance Criteria and Reported Device Performance:

   Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
   Dimension	ASTM standard D 5250-00c4	Meets
   Physical Properties	ASTM standard D 5250-00c4	Meets
   Freedom from pinholes	21 CFR 800.20	Meets
   Powder Amount	ASTM standard D 5250-00c4	Meets
   Biocompatibility (extract.)	Not specified (implied

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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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard I) 525()-00'd

The provided text is for a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. The information focuses on regulatory compliance based on established standards rather than a study proving the device meets acceptance criteria through clinical or comparative effectiveness trials.

Here's a breakdown based on your request, highlighting the information that is not present in the provided document, as it's not typically required for this type of device and submission:

Acceptance Criteria and Reported Device Performance

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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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, White (Non-colored)":

1. Table of Acceptance Criteria and Reported Device Performance

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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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.

This document is a 510(k) Premarket Notification summary for medical gloves, not a study of an AI device. As such, it does not contain the information requested in your prompt regarding AI device acceptance criteria and study details.

However, I can extract the relevant information about the device performance and acceptance criteria for the medical gloves as presented in this document.

1. A table of acceptance criteria and the reported device performance:

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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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

The provided document describes the safety and effectiveness information for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)" submitted by ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD. The study presented is a non-clinical evaluation comparing the device's technical characteristics against established standards.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4

The provided text describes the regulatory submission for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and its equivalence to a predicate device, primarily through adherence to established standards.

Here's an analysis of the acceptance criteria and the study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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