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A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient.

Powdered Latex Examination Gloves with Protein and Powder Claim (100 MICROGRAMS OF LESS)

The provided text is a 510(k) pre-market notification letter from the FDA regarding "Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim (100 micrograms or less)". This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, or performance results of a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is strictly for regulatory approval of a medical device based on substantial equivalence.

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With Protein Content Labeling Claim (100 micrograms or less of total water extractable Protein per gram). A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

BLOSSOM™ Powdered Latex Examination Gloves

The provided text is a 510(k) clearance letter from the FDA for "Blossom™ Powdered Latex Examination Gloves with Protein Content Labeling Claim (100 micrograms or less)." This document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment related to a study proving the device meets acceptance criteria.

The letter is primarily a regulatory communication stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It confirms that the device can be marketed subject to general controls provisions.

Therefore, I cannot provide the requested information based on the input text. The questions posed are typically answered in a detailed study report or a 510(k) summary (which is generally distinct from the clearance letter itself) that would describe the testing performed to support the protein content claim.

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