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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Polymer Coated Powder Free Nitrile Examination Gloves, BLUE

I am sorry, but the provided text is a government document from the Food and Drug Administration (FDA) and does not contain the specific information you are looking for regarding acceptance criteria, study details, or AI performance metrics. It is a 510(k) clearance letter for a medical device (nitrile examination gloves) and an "Indications for Use Statement." These documents typically focus on regulatory compliance and the intended use of the device, rather than detailed performance studies against specific acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study details or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Polymer Coated, Powder Free, Latex Examination Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LES

This document is a 510(k) premarket notification from the FDA, specifically concerning "Latex Examination Glove, Polymer Coated." It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a regulatory approval letter and an "Indication for Use Statement" for the glove.

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

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Pre-Powdered Nitrile Examination Gloves

This document is a 510(k) premarket notification decision letter from the FDA to FLEXITECH SDN. BHD. regarding "Pre-Powdered Nitrile Examination Gloves." This is not a study document that describes acceptance criteria and device performance data.

Therefore, I cannot provide the requested information from this document. It does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is primarily an FDA clearance letter for a medical device (nitrile gloves) based on substantial equivalence to a predicate device, rather than a report detailing performance studies against specific acceptance criteria for an AI/algorithm-based device.

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

PrePowdered Latex Examination Gloves with Protein claim.

This document is a 510(k) premarket notification approval letter for "Pre-Powdered Latex Examination Gloves" from FLEXITECH SDN. BHD. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices.

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

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves. (Green and Blue)

This is a 510(k) premarket notification for "Powder-Free Nitrile Examination Gloves (Green and Blue)" by FLEXITECH SDN. BHD. The document is an FDA letter stating substantial equivalence and an "Indication For Use" statement. It does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. Therefore, I cannot generate the requested information based on the provided text.

The document is primarily a regulatory communication outlining the FDA's decision to permit the marketing of the device due to substantial equivalence to a legally marketed predicate device. It briefly mentions the intended use of the gloves but does not delve into performance metrics or study data.

Ask a specific question about this device

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, with protein labeling claim (50 micrograms or less)

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets these criteria. The document is an FDA 510(k) clearance letter for "Powder-Free Natural, Blue, and Green Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less)" from FLEXITECH SDN. BHD.

It primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also includes an "Indications for Use Statement" for the gloves.

Therefore, I cannot provide the requested information.

Ask a specific question about this device