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This Surgeon's glove is a device made of natural rubber intended to be worn by This Surgeon's glove to a so notect a surgical wound from contamination.

Sensiflex Plus, Polymer Coated Latex Surgical Glove Powder Free, Sterile, Coated with Aloe Vera, contains 50 micrograms or less of total water extractable protein per gram.

This document is a 510(k) premarket notification decision letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software devices. The acceptance criteria for this type of device (surgical glove) are generally related to manufacturing standards, material properties, and sterility, which would be covered by general controls and specific standards for gloves.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the product.

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