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The powdered vinyl patient examination glove, clear (non-colored) 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. The powder is made from cornstarch. It is color free and is sold as non sterile.

Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.

The provided text describes the performance of "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)" (or other clients private labeling) to demonstrate substantial equivalence to predicate devices, rather than a device that employs AI or requires complex studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this type of device submission.

The acceptance criteria and device performance are based on meeting established consensus standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

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