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

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This document is a 510(k) clearance letter from the FDA for a medical device: "Teh Loong Vinyl, Powder-Free Patient Examination Glove." It is not a study report, and therefore does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device is considered safe and effective because it is similar enough to existing devices that have already been cleared by the FDA. The letter does not describe any specific studies performed by the manufacturer to prove performance against acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text.

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

Vinyl Powdered Patient Examination Gloves

I am sorry, but the provided text from the FDA letter about "Teh Loong Vinyl, Powdered Patient Examination Gloves" (K993847) is a clearance letter for a 510(k) submission. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This type of document does not contain the detailed information necessary to answer your request about acceptance criteria, study design, expert qualifications, or comparative effectiveness. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot extract the information required to populate the table and answer the specific questions you've posed.

Ask a specific question about this device