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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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BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 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.

BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.

This letter is a 510(k) clearance for "Brightway™ Brand Latex Surgical Gloves - Sterile (Powder Free)". It indicates the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data for the gloves.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the provided document.

The document is a regulatory approval letter, which confirms the device can be marketed based on its substantial equivalence to another device, but it does not detail the technical performance studies.

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BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powdered containing 150 ugm or less of water extractable protein per grain is a usposable passimilar personnel to prevent contamination between patient and examiner.

BRIGHTWAY™ Brand Blue Color Latex Examination Gloves, Powdered containing 150 μgm or less of water extractable protein per gram.

This document is a 510(k) clearance letter from the FDA for a medical device: "BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powdered."

It does not contain information related to acceptance criteria, device performance studies, sample sizes, expert involvement, or any other details typically associated with the evaluation of a device's effectiveness or safety through clinical or performance studies that would use such metrics.

Instead, this letter confirms that the device has been found "substantially equivalent" to predicate devices already on the market, meaning it has the same intended use and technological characteristics as a legally marketed device or, if there are differences, those differences do not raise new questions of safety or effectiveness.

Therefore, I cannot extract the requested information from the provided text.

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BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powder Free containing 50 ugm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of the examiner to prevent contamination between patient and examiner.

BRIGHTWAY™ Brand Blue Color Latex Examination Gloves, Powder Free containing 50 µgm or less of water extractable protein per gram.

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information. This document pertains to a medical device (latex examination gloves) and not an AI-powered device.

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