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The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.

The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.

The provided text is an FDA 510(k) clearance letter for a medical device: "Powder Free Vinyl Patient Examination Glove." This document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria for a diagnostic algorithm or AI-powered medical device.

The letter explicitly states:

• Device Name: Powder Free Vinyl Patient Examination Glove
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: Class I, reserved
• Product Code: LYZ

This is a physical, disposable medical glove, not a diagnostic algorithm or an AI system. The 510(k) clearance for such a device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, typically through performance standards for physical properties, biocompatibility, and manufacturing processes, rather than the type of clinical study outlined in your request (e.g., MRMC, standalone algorithm performance, ground truth establishment for AI/diagnostic devices).

Therefore, I cannot fulfill your request using the provided text because it describes a completely different type of medical device and does not include the information you've asked for regarding acceptance criteria and performance studies for an AI or diagnostic algorithm.

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A Powder Free Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Vinyl Examination Gloves

I regret that I cannot fulfill your request to describe the acceptance criteria and study for a medical device based on the provided text. The document you've shared is an FDA 510(k) clearance letter for "Powder Free Vinyl Examination Glove" (K122377).

This type of document primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device. It does not typically contain the detailed information about acceptance criteria, the specific studies performed to prove the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment that you've requested.

The FDA 510(k) clearance process for Class I devices like examination gloves often relies on demonstrating equivalence to existing devices rather than requiring extensive de novo clinical trials with detailed performance metrics and statistical analyses as might be seen for higher-risk devices or novel technologies.

Therefore, the information necessary to answer your specific questions (e.g., a table of acceptance criteria and performance, sample sizes for test/training sets, details on expert ground truth, MRMC studies, standalone performance) is not available within these pages.

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A patient examination Vinyl Powder Free Gloves is a disposable device Intended for medical patient and examiner. A patient examination vinyl in the is worn on the examiner' device Intended for medical patient and examiner.

Powder Free Vinyl Examination Glove

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Vinyl Examination Glove" and an "Indications for Use" statement.

This document does not contain information about the acceptance criteria and study results for an AI/device's performance as typically requested for medical AI devices. It details the FDA's decision regarding substantial equivalence for a medical glove, which is a physical device, not a software or AI-driven diagnostic tool.

Therefore, I cannot extract the requested information such as test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment, as this information is not present in the provided text.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 380,6250. Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 E4

The provided text describes a 510(k) summary for a "Powder free Vinyl Examination Glove" and focuses on establishing its substantial equivalence to a predicate device, rather than presenting a study demonstrating acceptance criteria met by the device itself in a typical AI/software context.

Therefore, many of the requested fields are not applicable to this type of submission. However, I will extract the available information and indicate where specifics about a performance study are missing.

Analysis of the Document for AI/Software Device Acceptance Criteria and Study:

The document describes a medical device, specifically a "Powder free Vinyl Examination Glove." This is a physical, disposable medical device, not an AI or software device. As such, the concept of "acceptance criteria" and "study" in the context of AI performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies, training/test sets) does not directly apply.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415). This is a regulatory pathway for Class I and Class II devices in the US, where the new device is shown to be as safe and effective as a legally marketed device.

Table of Acceptance Criteria and Reported Device Performance (as translated for a physical device and substantial equivalence):

Missing Information (Not applicable to this type of device/submission):

The following information is primarily relevant for AI/software-based medical devices and is therefore not found in this 510(k) submission for a physical glove:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical glove. Performance is typically assessed through physical testing (e.g., tensile strength, puncture resistance, barrier integrity) against established standards (like ASTM D5250-00 E4) rather than data from a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a glove involves objective measurements and compliance with material standards, not expert interpretation of data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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, as this is not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical glove, the "ground truth" would be objective measurements against an engineering standard (e.g., ASTM D5250-00 E4), not expert consensus or pathology.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (examination glove) seeking substantial equivalence to a predicate device. It demonstrates performance by claiming adherence to an ASTM standard and direct comparison of characteristics to a previously cleared device, not through an AI-style performance study with test sets, ground truths, or expert evaluations.

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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

I'm sorry, but without further context, I cannot fulfill your request for information about acceptance criteria and study results. The provided text is a letter from the FDA to a medical device company regarding the 510(k) clearance of "Powder Free Vinyl Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the following information that you requested:

• A table of acceptance criteria and reported device performance. The FDA letter is a regulatory approval, not a performance study report.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance. (This is not an AI/algorithm device).
• Type of ground truth used.
• Sample size for the training set.
• How ground truth was established for the training set.

The document only states the "Indication For Use" for the gloves, which is: "A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient."

To answer your request, I would need a different type of document, such as a clinical study report, a scientific publication, or a detailed technical submission to a regulatory body that specifically outlines performance testing and acceptance criteria for a medical device that would not be typical of examination gloves.

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Ask a specific question about this device