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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.

Pre-powdered Nitrile Examination Gloves

The document is a 510(k) clearance letter from the FDA for "Pre-Powdered Nitrile Examination Gloves" manufactured by P.T. Latexindo Tobaperkasa. It states that the device is substantially equivalent to devices marketed before May 28, 1976, and therefore can be marketed.

This document is a regulatory clearance letter, not a study report or technical specification detailing performance criteria and a study proving those criteria were met. Therefore, none of the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth, expert involvement, adjudication, or MRMC studies can be extracted from this document.

The letter confirms the device's classification and substantial equivalence but does not provide the technical data or study results that would typically be included in a submission demonstrating performance against specific acceptance criteria.

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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.

Powder Free Nitrile Examination Gloves (Polymer Coated)

This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a notification of substantial equivalence for "Powdered Free Nitrile Examination Gloves (Polymer Coated)."

Therefore, I cannot provide the requested information based on the input document.

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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.

Powder Free Latex Patient Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA regarding "Hi Coat Powder-Free Latex Patient Examination Gloves." It does not contain any information about acceptance criteria or a study proving device performance in the way typically found for AI/ML medical devices.

Instead, this document is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices. This means the device's safety and effectiveness are established by demonstrating it is as safe and effective as another legally marketed device and does not raise different questions of safety and effectiveness.

Therefore, I cannot fulfill your request for the specific points because the document does not contain that type of information. It addresses regulatory compliance, not performance study details.

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