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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Powdered Latex Patient Examination Gloves

The provided text is a 510(k) clearance letter from the FDA for "POWDERED LATEX PATIENT EXAMINATION GLOVES." It outlines the regulatory status and general controls for the device but does not contain the type of AI/ML device performance study details requested.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the document does not relate to an AI/ML device and does not describe such a study.

The document states:

• Device Name: POWDERED LATEX PATIENT EXAMINATION GLOVES
• Regulation Name: Patient Examination Glove
• Regulatory Class: I
• Product Code: LYY
• Indications for Use: "A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)"

This is a traditional medical device (gloves), not an AI/ML diagnostic or prognostic tool, and therefore the concepts of "acceptance criteria" based on AI performance metrics, test/training sets, ground truth establishment, or MRMC studies do not apply to this specific FDA submission.

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

Prepowdered Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro)

This is a 510(k) premarket notification for disposable pre-powdered synthetic vinyl patient examination gloves. The provided documents do not contain information about acceptance criteria or a study with performance data for this device. The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include detailed performance testing results.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

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

Powder Free Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro)

I am sorry, but the provided text does not contain the information requested to answer the question about the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for disposable powder-free synthetic vinyl patient examination gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices but does not detail acceptance criteria, study methodologies, or performance data beyond the device's intended use.

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

Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves

This is a 510(k) clearance letter for disposable examination gloves. This type of device does not typically involve the kind of "acceptance criteria" and "study" that would be performed for AI/ML-powered medical devices as your questions imply. The FDA clearance process for these devices primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to performance metrics against specific criteria for an algorithm.

Therefore, I cannot answer the questions directly as they are not applicable to the provided document. The document describes a traditional medical device (disposable gloves) and its regulatory clearance, not an AI/ML device.

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A patient examination gloves is a disposabledevice intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Synthetic Examination Gloves, White color(Sensi-Pro)

This document is a 510(k) clearance letter from the FDA for "Sensi-Pro Disposable Powder Free Vinyl Synthetic Examination Gloves". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/software-as-a-medical-device (SaMD) products.

The information requested in your prompt (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is highly specific to the evaluation of AI/SaMD devices, which are assessed for their diagnostic or predictive accuracy.

This document is for a physical medical device (examination gloves), which are evaluated based on physical and mechanical properties, barrier integrity, and biocompatibility, not AI performance metrics. Therefore, the requested information is not relevant to this type of device and is not present in the provided text.

To answer your prompt directly based on the provided text, I must state:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document is for examination gloves, not an AI/SaMD. Criteria would relate to physical properties, not diagnostic accuracy.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for AI performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI performance is mentioned.
4. Adjudication method for the test set: Not applicable. No test set for AI performance is mentioned.
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 pertains to physical examination gloves, not an AI system that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to physical examination gloves, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for AI performance is mentioned.
8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided FDA 510(k) letter is for a medical device (gloves) that does not involve artificial intelligence or software-as-a-medical-device. Consequently, none of the specific details requested about AI/SaMD performance evaluation are present or applicable.

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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Powder Free Vinyl Examination Gloves

This document is related to a 510(k) premarket notification for "Powder Free Vinyl Examination Gloves" and is a letter from the FDA to Shinemound Enterprise, Incorporated, confirming that their device is substantially equivalent to legally marketed predicate devices.

As such, this document does not contain information about acceptance criteria and a study that proves the device meets the acceptance criteria.

The document primarily focuses on:

• The FDA's determination of substantial equivalence (K971360).
• The regulatory classification of the device (Class I).
• General controls provisions applicable to the device.
• Contact information for various FDA offices.
• An "Indication For Use Statement" for the gloves.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this material.

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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Powdered Vinyl Synthetic Examination Gloves

This document is a 510(k) premarket notification decision letter from the FDA to Shinemound Enterprise, Incorporated, concerning "Powdered Vinyl Synthetic Examination Gloves."

The provided text is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets criteria.

Therefore, I cannot provide the requested information. The document solely states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for the indicated use (as a medical disposable glove worn by healthcare personnel to prevent contamination).

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