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Powder Free Vinyl Patient Examination Gloves, Colored (White) 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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.

This 510(k) summary describes the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (White) marketed by TANGSHAN HENGDA PLASTIC PRODUCTS CO.,LTD.

1. Table of Acceptance Criteria and Reported Device Performance:

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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow), 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)". This is a medical device and not an AI/ML powered device, therefore most of the requested information (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance) is not applicable or not found in the document.

Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable or not found:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device