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The G-Derm™ Surgical Glove is a disposable sterile powder-free medical device made of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styreneethylene/propylene (SEPSEP) synthetic copolymers that is intended to be worn by operating room personnel to protect a surgical wound from contamination.

The G-Derm™ Powder Free Surgical Glove is made of a blend of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers. It is coated with a polyurethane based coating on the inner side to facilitate donning.

The provided text describes a 510(k) submission for the Hutchinson Santé G-Derm™ Surgical Glove, a Class I medical device. The submission focuses on demonstrating substantial equivalence to predicate devices through performance data and adherence to recognized standards, rather than an AI-driven diagnostic or prescriptive device requiring complex clinical studies. As such, many of the requested categories (like MRMC studies, number of experts for ground truth, adjudication methods, training set information) are not applicable to this type of device submission.

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Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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