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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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A medical glove is worn on the hand of health care and similar personnel and the patient, A medical glove is worn on one nation between health

BLOSSOM TM Powdered Latex Examination Gloves

I am sorry, but the provided text from the FDA letter and the associated pages (sections 0, 1, and 2) do not contain any information about acceptance criteria or a study proving that a device meets those criteria.

The document is an FDA 510(k) clearance letter for "Blossom Powdered Latex Examination Gloves." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Key information present in the document includes:

• Device Name: Blossom Powdered Latex Examination Gloves
• Applicant: Mexpo International, Incorporated
• 510(k) Number: K984040
• Regulatory Class: I
• Product Code: LYY
• Indications for Use: "A medical glove is worn on the hand of health care and similar personnel and the patient." (This is a generic description for medical gloves and not specific performance criteria).

Therefore, I cannot provide the requested table or details about a study, as that information is not available in the given text.

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A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

SUPERGLOVES Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.

The document is an FDA 510(k) clearance letter for "SUPERGLOVES® Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)". It confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The letter mentions general controls provisions and regulatory requirements but does not include any performance study data or detailed acceptance criteria.

The "Indications for Use" section defines what the gloves are for, but it does not contain any performance metrics or criteria.

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