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A patient examination glove is a disposable device intended for medical purposes that is I x partient examiner's hand or finger to prevent contamination between patient and examiner.

Pre-Powdered, Non-Sterile, Vinyl Exam Gloves, Yellow

The provided text is a 510(k) premarket notification letter from the FDA regarding "Pre-Powdered, Non-Sterile, Vinyl Exam Gloves, Yellow." This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain information about:

• Acceptance criteria and reported device performance beyond regulatory substantial equivalence.
• Any specific study (like a clinical trial or performance study) proving the device meets performance-based acceptance criteria. The 510(k) process primarily assesses substantial equivalence to a predicate device, which usually involves comparing design, materials, chemical composition, energy source, manufacturing process, and intended use, and often does not require new clinical efficacy or performance studies if the device is similar enough to a legally marketed one.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. These are typically associated with performance studies for more complex or novel medical devices, especially those involving AI/ML.

The device in question, patient examination gloves, is a Class I medical device, which generally has lower regulatory hurdles and typically does not require extensive performance studies as described in the prompt's request. The substantial equivalence determination is based on the device's similarity to existing gloves already on the market.

Therefore, based solely on the provided text, I cannot populate the requested table and answer the study-specific questions. The document confirms regulatory clearance but does not detail the type of performance data or studies that would involve the metrics requested.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

VINYL EXAM GLOVES, POWDER-FREE, YELLOW

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria.

The document is a US FDA 510(k) clearance letter for "Vinyl Exam Gloves, Powder Free, Yellow." It states that the device is substantially equivalent to legally marketed predicate devices. This type of clearance relies on demonstrating substantial equivalence to pre-existing devices, rather than presenting new performance study data against specific acceptance criteria.

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

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE

This document is a 510(k) premarket notification letter from the FDA regarding a Vinyl Examination Glove. It is not a study report or clinical trial. Therefore, it does not contain any information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
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 letter solely communicates the FDA's determination of substantial equivalence for the Vinyl Examination Glove to legally marketed predicate devices, allowing it to proceed to market subject to general controls. It does not provide detailed performance data or study specifics.

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Ask a specific question about this device

Ask a specific question about this device