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Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE

This document is a 510(k) clearance letter from the FDA for a medical device: "Synthetic Vinyl Medical Examination Powder Free Glove" manufactured by Top Glove Sdn. Bhd. It concerns regulatory clearance for marketing the device, not a study report or acceptance criteria for a specific performance characteristic of the glove itself (e.g., tear resistance, sterility, absence of holes).

Therefore, based on the provided document, I cannot answer the questions about acceptance criteria and a study proving the device meets those criteria. The letter addresses the device's substantial equivalence to a predicate device, allowing it to be marketed, rather than presenting a performance study.

Here's why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This document does not contain any performance acceptance criteria or reported device performance data for the gloves (e.g., tensile strength, puncture resistance, barrier integrity). It's a regulatory clearance, not a test report.

2. Sample sized used for the test set and the data provenance: Not applicable, as no performance test data or test set is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance test data or ground truth establishment is discussed.

4. Adjudication method for the test set: Not applicable, as no performance test data or adjudication is discussed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for medical examination gloves and does not involve AI or human readers for diagnostic purposes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a physical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as ground truth is relevant for diagnostic or AI performance studies, which this is not.

8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this is a physical medical device, not an AI algorithm.

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