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Powder free vinyl 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes the regulatory submission for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" and a specific sample size for each test. Instead, it refers to the standards themselves (e.g., ASTM D 5250-06, 21 CFR 800.20, D6124-06, ISO10993-10), implying that the testing was conducted according to the sampling plans and methodologies outlined in those standards.

• Sample Size: Not explicitly stated as a single number for a "test set." The sample sizes would be those prescribed by the referenced ASTM and ISO standards for each specific test (e.g., for pinhole testing, physical properties, biocompatibility studies).
• Data Provenance: The document indicates that the submitter is HEBEI TENGDA PLASTIC CO., LTD from SHIJIAZHUANG, CHINA. The testing was conducted by or on behalf of this company to demonstrate compliance with the relevant standards. The data is retrospective in the sense that the tests were performed on finished products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The "ground truth" for patient examination gloves is established by objective physical and chemical testing against defined standards. It does not involve expert consensus on interpretations like medical images.

4. Adjudication method for the test set

This information is not applicable. Adjudication refers to processes for resolving disagreements in expert opinions, typically in diagnostic or interpretative studies. For glove testing, the results are quantitative or pass/fail based on objective measurements against predefined acceptance criteria from standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. Patient examination gloves are physical barriers and do not involve such interpretative tasks.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical product (gloves), not an algorithm or an AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used

The "ground truth" is defined by objective physical and chemical measurements performed in accordance with recognized international and national standards:

• ASTM standard D 5250-06: For dimensions and physical properties.
• 21 CFR 800.20: For freedom from pinholes (waterleak test).
• ASTM standard D 6124-06: For powder residual.
• ISO10993-10: For biocompatibility (primary skin irritation and dermal sensitization tests).

The "ground truth" is whether the glove samples objectively meet the specified quantitative and qualitative criteria defined by these standards.

8. The sample size for the training set

This information is not applicable. This submission is for a physical medical device (gloves), not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8. There is no training set for a physical device like examination gloves.

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document describes the acceptance criteria and the study results for the Hebei Tengda Plastic Co., Ltd. Powdered Vinyl Patient Examination Gloves, Clear (Non-colored).

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the specific sample sizes used for each of the tests (Dimension, Physical Properties, Freedom from pinholes, Powder Amount, Biocompatibility). However, it indicates compliance with recognized standards (ASTM D 5250-06, 21 CFR 800.20, ISO10993-10), which inherently define the testing methodologies and sample sizes required for compliance.

The data provenance is from nonclinical studies conducted to demonstrate substantial equivalence. The document does not specify the country of origin where these tests were performed, but it is submitted by a Chinese manufacturer (Hebei Tengda Plastic Co., Ltd.) to the US FDA. The studies would be considered retrospective in the context of this 510(k) submission, as they were conducted prior to the submission to demonstrate compliance.

3. Number of Experts and Qualifications for Ground Truth for Test Set

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing ground truth in the way medical imaging or diagnostic AI devices do. The "ground truth" for the performance criteria is established by the well-defined and objective metrics within the ASTM and FDA standards. Therefore, information about the number of experts or their qualifications for establishing ground truth is not applicable in this context.

4. Adjudication Method for Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical image reading) to resolve disagreements among experts. Since the tests for glove performance are objective and based on measurable physical and chemical properties, an adjudication method is not applicable. The results are directly compared against the quantitative thresholds defined by the standards.

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

No MRMC study was conducted or is applicable for this device. This device is a physical medical device (gloves), not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical product, not an algorithm.

7. Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory requirements, specifically:

• ASTM standard D 5250-06 (for Dimension, Physical Properties, Powder Amount)
• 21 CFR 800.20 (for Freedom from pinholes)
• ISO10993-10 (for Biocompatibility testing, although not explicitly listed in the performance table, it's mentioned as a standard met)

These standards define objective and measurable criteria that the device must meet.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for a physical device.

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