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A patient examination glove 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.

Vinyl Examination Gloves, Powder Free, Green Color

This document, a 510(k) premarket notification approval letter, does not contain the detailed information necessary to fully answer all aspects of your request. The letter confirms that Vinyl Examination Gloves, Powder Free, Green Color, manufactured by Arista Latindo Industrial Limited PT, are substantially equivalent to legally marketed predicate devices. However, it does not include a study describing acceptance criteria and device performance in the way you've outlined for an AI/CAD product.

Here's a breakdown of what can and cannot be extracted from the provided text:

Information Available:

• Device Name: Vinyl Examination Gloves, Powder Free, Green Color
• Intended Use/Indications for Use: "A patient examination glove 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."
• Regulatory Class: I
• Product Code: LYZ

Information NOT available in this document:

This document is a marketing clearance for a simple medical device (gloves) and therefore does not include the kind of detailed performance study information typically associated with AI/CAD devices. Specifically, it does not contain:

1. A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc., as would be expected for an AI/CAD system).
2. Sample size used for a test set or data provenance (country, retrospective/prospective).
3. Number of experts, their qualifications, or methods to establish ground truth for a test set.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (pathology, expert consensus, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

To answer your request, if this were an AI/CAD device, the 510(k) submission itself (which this letter refers to) would contain the study details you are looking for, not the approval letter. For devices like these gloves, the "performance" is generally assessed against established manufacturing standards (e.g., tensile strength, barrier integrity, dimensions, biocompatibility) rather than diagnostic accuracy metrics.

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A patient examination glove 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.

Vinyl Examination Gloves, Powder Free, Pink Color

This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves, Powder Free, Pink Color." It states that the device is substantially equivalent to legally marketed predicate devices.

The information provided in the document does not contain details about acceptance criteria, device performance, study types, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device in a clinical or diagnostic context.

Instead, the document primarily focuses on the regulatory approval process for a patient examination glove, confirming its substantial equivalence to predicate devices for its intended use (preventing contamination between patient and examiner). The "Indicators For Use" section defines the product, but does not specify performance metrics.

Therefore, I cannot provide the requested information based on the input text. The text is a regulatory approval letter, not a performance study report.

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A patient examination glove 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.

Vinyl Examination Gloves, Powder Free, Violet Color

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device. The text is a 510(k) premarket notification letter from the FDA to a medical glove manufacturer, confirming the substantial equivalence of their "Vinyl Examination Gloves, Powder Free, Violet Color" to a legally marketed predicate device.

The document discusses regulatory compliance for patient examination gloves but does not contain any scientific study data, performance metrics, or details about how the device's efficacy or safety was evaluated using acceptance criteria.

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Ask a specific question about this device

Ask a specific question about this device

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.

Class 1 vinyl patient examination glove 80LYZ, powder-free, that meets all the requirements of ASTM D 5250 - 92.

This submission is for a medical device called "GG" vinyl examination gloves, powder-free, which falls under the classification of Patient examination glove (per 21 CFR 880.6250). The device is intended for medical purposes as a disposable item worn on the examiner's hand or finger to prevent contamination between the patient and examiner.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "GG" vinyl examination gloves, powder-free, are based on the ASTM standard D 5250 - 92, and FDA pinhole requirements. The document indicates that the device's performance "meets or exceeds the ASTM or equivalent standard" and "meets FDA pinhole requirements."

Note on "Reported Device Performance": The provided text explicitly states that the gloves "meet or exceed the ASTM or equivalent standard" and "meet FDA pinhole requirements." For specific numerical criteria like tensile strength and ultimate elongation, the document lists the reported values as 9.0 Mpa (min) and 300% (min) respectively, which directly match the minimum requirements. For dimension and tolerance, the table simply states "Meets/Exceeds ASTM D 5250" as specific measured values for each size are not provided, only the general standard of compliance.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set in the same way clinical trials report them. Instead, it refers to "Inspection level S-2, AQL 4.0" for both dimension and tolerance and physical requirements. These are sampling plans specified in quality control standards (like ISO 2859-1 or MIL-STD-105E, of which AQL is a part) for attribute sampling.

• Sample Size for Test Set: Not explicitly stated as a number of devices/gloves. It refers to "Inspection level S-2, AQL 4.0," which defines a sampling plan from which sample sizes are derived based on batch size. The specific sample size for a given batch size would need to be looked up in the relevant AQL tables.
• Data Provenance: The data is generated from the manufacturer in Taiwan, R.O.C. (General Gloves Corp., No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733). The data appears to be prospective as it involves performance testing of the manufactured product against established standards.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable in the context of this device. The ground truth for examination gloves is based on established engineering and material standards (like ASTM D 5250 - 92) and regulatory requirements (like FDA pinhole requirements), not on expert consensus or interpretation of medical images. The "experts" are the engineers and quality control personnel performing the tests according to the standard operating procedures derived from ASTM.

4. Adjudication Method for the Test Set

This is not applicable for this type of device testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image-based diagnostic studies where there's subjectivity and potential for disagreement among human readers or interpreters. For physical and dimensional testing of gloves against a standard, the results are typically quantitative measurements or pass/fail criteria based on objective methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study assesses the effectiveness of human readers (e.g., radiologists) with and without AI assistance in diagnostic tasks. Since this device is a physical examination glove, there are no "human readers" in a diagnostic context, and therefore, no AI assistance to compare.

6. Standalone (Algorithm Only) Performance

This is not applicable. This device is a physical product (gloves), not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on established engineering standards and regulatory requirements. Specifically:

• ASTM D 5250 - 92: This standard defines the requirements for dimensions, tensile strength, and ultimate elongation for vinyl patient examination gloves.
• FDA Pinhole Requirements: These are regulatory standards for the barrier integrity of examination gloves.

8. Sample Size for the Training Set

This is not applicable. The concept of a "training set" and "test set" in the context of machine learning or AI is not relevant to the evaluation of a physical product like examination gloves. The manufacturing process of gloves does not involve machine learning models that are "trained."

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as #8. There is no training set in the context of this device's regulatory submission.

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