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

Powder Free Nitrile Examination Gloves, Black Powder Free Nitrile Examination Gloves, Blue, Grape Scented

This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The letter is a standard FDA communication confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements that the manufacturer must adhere to.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set size, or ground truth establishment for the training set) from the provided text. This information would typically be found in a separate study report or regulatory submission document describing the performance testing.

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

Smart Savers, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray color

This document is a 510(k) premarket notification letter from the FDA to Platinum Glove Industries Sdn Bhd for their "Smart Savers, Powder Free Nitrile Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

The document does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth, or any other details related to AI/algorithm performance studies. The context of the request is entirely focused on what would be found in a study for an AI-powered medical device, which is not applicable here.

Therefore, I cannot provide the requested information based on 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 With Peppermint Scented (Blue Color)

The provided document is a 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves with Peppermint Scented (Blue Color)." This document is a regulatory approval letter for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria.

The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the new device to existing devices that have already been cleared. For devices like examination gloves, the substantial equivalence typically involves demonstrating similar materials, performance characteristics (e.g., barrier integrity, tensile strength), and intended use as the predicate device, rather than a clinical study as would be required for more complex devices.

Therefore, I cannot provide the requested information, as it is not present in the given text.

To answer your specific questions in the context of what would typically be part of a submission for such a device, but which are not detailed in this specific letter:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. For examination gloves, acceptance criteria would typically relate to physical properties like tensile strength, elongation, force at break, viral penetration, and freedom from holes, often adhering to international standards (e.g., ASTM D6319 for Nitrile Examination Gloves).
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and submission. "Ground truth" in this context would typically refer to laboratory test results.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for diagnostic devices or AI algorithms where human interpretation is involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used: Not explicitly stated, but for examination gloves, "ground truth" refers to laboratory measurements of physical and barrier properties against established standards.
8. The sample size for the training set: Not applicable; this device does not involve machine learning.
9. How the ground truth for the training set was established: Not applicable.

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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, Green and White color.

The provided document is an FDA 510(k) Pre-market Notification letter for Polymer Coated Powder Free Nitrile Examination Gloves. This type of document is a regulatory approval and does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based medical device.

The questions you've asked are typical for studies evaluating the performance of algorithms or diagnostic devices (often involving AI/ML), where there's a need to establish sensitivity, specificity, accuracy, and compare to a ground truth established by experts.

This document, however, pertains to a physical medical device (examination gloves) and focuses on substantial equivalence to a predicate device, as per the FDA 510(k) process for Class I devices. The "performance" for such a device is typically assessed through physical properties and safety standards, rather than diagnostic accuracy metrics.

Therefore, I cannot extract the requested information from this document.

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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 (White, Blue and Purple Color)

I am sorry, but based on the provided document, I cannot extract the information required to answer your request.

The document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves." It focuses on the regulatory approval process, substantial equivalence to predicate devices, and the intended use of the gloves.

There is no mention of:

• Acceptance criteria for device performance (other than the implied safety and efficacy for medical gloves).
• Any specific studies proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Expert qualifications or ground truth establishment.
• MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot populate the table or provide the detailed study information you requested.

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