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BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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This document is a 510(k) clearance letter from the FDA for "BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered)". It is a regulatory approval document and does not contain the requested information about acceptance criteria or a study proving the device meets those criteria.

The document only states the device's intended use and that it is substantially equivalent to legally marketed predicate devices. It also mentions a specific parameter: "containing 150 µgm or less of water extractable protein per gram." While this is a characteristic of the device, the document does not present it as an acceptance criterion from a study or provide any study details.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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