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The Biogel Orthopedic Surgeon's Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel Orthodepic Surgical Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Biogel Orthopedic Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel clinical effectiveness with extensive studies. As such, many of the requested elements (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or training set details) are not relevant or typically included in such filings for this class of device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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