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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.

This document describes the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by SHANDONG JUNFENG INDUSTRIES CO., LTD.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test within the ASTM standards or the biocompatibility tests. However, the tests performed (e.g., freedom from pinholes, powder residual, primary skin irritation, dermal sensitization) imply that samples of the gloves were rigorously tested according to the specified international and national standards.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective," but the testing was conducted to meet established standards like ASTM and ISO, which are internationally recognized. The testing would have been prospective in nature, as the device was manufactured and then tested against these criteria to demonstrate compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable in the context of device performance testing against established standards for patient examination gloves. The "ground truth" here is defined by the objective metrics and thresholds set out in the ASTM and ISO standards themselves, not by expert consensus on qualitative observations. The product simply had to "meet" the quantitative or qualitative pass/fail criteria of these standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple experts. This is not relevant for the objective performance testing described for these gloves. The device performance was evaluated directly against the quantitative and qualitative requirements of the listed standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on diagnostic accuracy. This is not applicable to patient examination gloves, which are physical barrier devices.

6. If a Standalone (i.e., algorithm only without Human-in-the-Loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. This concept is applicable to AI/ML software devices. The device in question is a physical medical device (gloves) and its performance is evaluated through material and physical property tests, not algorithmic performance.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation comprises:

• Objective Standards: Defined by international and national consensus standards such as ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10. These standards specify precise methodologies for testing and define quantifiable pass/fail criteria (e.g., maximum allowable pinholes, maximum powder residual, specific methods for biocompatibility testing).
• Laboratory Testing Results: The "Meets" or "Passes" reported for each characteristic directly reflects the results of laboratory tests conducted in accordance with these objective standards.

8. The Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning or AI. The device is a physical product (gloves), not an AI algorithm. Therefore, the concept of a training set is not applicable. The manufacturer produces the gloves, and then tested samples from production lots against the outlined standards.

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

As explained in point 8, the concept of a "training set" is not applicable to this device. Therefore, no ground truth was established for a training set. The "ground truth" for the device's acceptable performance is derived from the established and publicly available standards it must meet.

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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)

The provided text describes the acceptance criteria and study for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The testing is described as meeting established standards (ASTM, FDA regulations, ISO).
The data provenance is not explicitly mentioned as retrospective or prospective, nor are specific countries of origin for the data provided beyond the manufacturer's location in China. The testing is non-clinical, primarily relying on performance against established industry standards.

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 device and its testing. The "ground truth" for these types of medical gloves is established by their adherence to defined physical, chemical, and biological performance standards, not by expert consensus in diagnostic interpretation. The standards themselves are developed by expert bodies.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For physical product testing against objective standards, the results are either pass or fail based on the standard's criteria.

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:

This is not applicable. This device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI are irrelevant.

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

This is not applicable. This device is a physical product (a glove), not a software algorithm.

7. The type of ground truth used:

The ground truth is established by industrial and regulatory standards.

• Physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual): The ground truth is defined by the objective pass/fail criteria outlined in ASTM D 5250-06, ASTM D6124-06, and 21 CFR 800.20. These are quantifiable measurements and thresholds.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The ground truth is established by the results of biological tests on animal models, as per ISO10993-10, demonstrating the absence of harmful irritant or sensitizing reactions.

8. The sample size for the training set:

This is not applicable. This device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development or evaluation.

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

This is not applicable as there is no training set for this device.

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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.

Acceptance Criteria and Study for Powder Free Vinyl Patient Examination Gloves

This device is a Class I medical device and does not require a complex clinical study for approval. The submission relies on non-clinical testing and adherence to established standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, or number of animals for biocompatibility). However, the tests are conducted in accordance with the referenced ASTM and ISO standards, which would define appropriate sample sizes for these types of assessments.

• Data Provenance: The device manufacturer is SHIJIAZHUANG BENESTAR PLASTIC CO., LTD. located in CHINA. The testing was conducted to meet international standards (ASTM and ISO) and US regulations (21 CFR).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Ground Truth Establishment: For this type of device and testing, "ground truth" is established by adherence to standardized testing protocols and objective measurements outlined in the referenced ASTM standards, 21 CFR, and ISO standard. There is no mention of human experts establishing ground truth for the test set beyond the qualified personnel performing the standardized laboratory tests.
• Qualifications of Experts: The document does not specify the qualifications of the individuals who performed the tests. It is assumed that these tests were conducted by trained technicians in laboratories accredited to perform such work in accordance with the respective standards.

4. Adjudication Method for the Test Set

Not applicable. The performance is assessed against objective, measurable criteria defined by the referenced standards, not through human adjudication of subjective data. (e.g. 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging software) where human interpretation is a key component. This device is a patient examination glove, and its effectiveness is determined by its physical properties and biocompatibility, not by human interpretation of its function.

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

This concept is not applicable to the device. "Standalone" performance usually refers to the performance of an AI algorithm without human involvement in interpretation or decision-making. Since this device is a physical glove, not an algorithm, this question is not relevant. The device itself is "standalone" in its function as a barrier.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements against established national and international standards. This includes:

• Physical measurements (e.g., dimensions)
• Mechanical property tests (e.g., tensile strength, elongation)
• Chemical residue analysis (powder residual)
• Barrier integrity tests (freedom from pinholes based on water leak AQL as per 21 CFR 800.20)
• Biocompatibility assessments based on animal models (primary skin irritation and dermal sensitization) as defined by ISO10993-10.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on its physical and biological properties.

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

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

Ask a specific question about this device

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.

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

Device: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Predicate Device: FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd. (K032908)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for any of the performance characteristics. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) is not provided. It only mentions that the data originates from "Hebei Handform Plastic Products Co., Ltd." in P.R. China, but not the specific origin of the test samples or the study design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the submission. For physical and chemical tests like those listed, ground truth is typically established by laboratory testing methods, not expert consensus in the way it would be for image-based diagnostic devices.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is relevant for studies where subjective interpretation is involved, such as reading medical images. For the physical and chemical tests listed for these examination gloves, adjudication methods are not applicable and therefore not mentioned. The results are objective measurements against defined standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to devices where human readers (e.g., radiologists) interpret cases, and the device aims to assist or improve their performance. The device in question is a medical glove, which does not involve human interpretation in its function.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The "Device performance" column in the table above reflects the algorithm-only performance (in this case, the product's performance) against the specified standards, without human-in-the-loop assistance in the interpretation of results. The device itself is the tested entity, and its performance metrics are directly measured.

7. Type of Ground Truth Used

The ground truth used for the reported performance metrics is based on defined industry standards and regulations:

• ASTM standard D 5250-06: For Dimension and Physical Properties.
• 21 CFR 800.20: For Freedom from pinholes.
• ASTM standard D 5250-06 and D6124-01: For Powder Residual.
• ISO10993-10: For Biocompatibility (Primary Skin Irritation and Dermal Sensitization).

These standards provide the objective criteria against which the device's measured properties are compared.

8. Sample Size for the Training Set

The concept of a "training set" applies to machine learning algorithms. Since these gloves are a physical medical device and not an AI/ML algorithm, there is no training set in the typical sense for this product. The manufacturing process and quality control would involve internal testing, but not "training data" as understood in AI/ML contexts.

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

As there is no training set for this type of device, the question of how its ground truth was established is not applicable.

Ask a specific question about this device

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.

Here's a breakdown of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for testing each characteristic. The data provenance is not explicitly stated in terms of country of origin for the individual tests, but the device manufacturer is based in China. The studies appear to be prospective as they are conducted to demonstrate the device meets specific standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For device testing (like these gloves), the "ground truth" is typically defined by the objective measurement adhering to the specified ASTM standards and CFR regulations, rather than expert consensus on subjective interpretations. For biocompatibility, the interpretation of results would be by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in scenarios where multiple human readers are assessing subjective data (e.g., medical images) and their disagreements need to be resolved. For objective tests on physical properties of gloves, the results are typically directly measured against a standard, not adjudicated by a panel of experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to the assessment of physical properties or biocompatibility of examination gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on objective measurements against established industry standards and regulatory requirements.

• ASTM standards (D 5250-06, D6124-01): These standards define the acceptable range for dimensions, physical properties, and powder residue. The ground truth is whether the measured values fall within these defined ranges.
• 21 CFR 800.20: This regulation defines the acceptable level of freedom from pinholes based on a water leak test. The ground truth is the pass/fail outcome of this test.
• ISO10993-10: This standard governs biocompatibility testing. The ground truth is the biological response observed (e.g., presence or absence of irritation/sensitization) as interpreted by standard toxicological protocols.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The development and testing of these gloves do not involve a "training set" in the context of machine learning or AI models. The gloves are manufactured and then tested against specified standards.

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

This information is not applicable as there is no "training set" for this type of device.

Ask a specific question about this device

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 5250-00ed.

Here's an analysis of the provided text regarding the acceptance criteria and study that proves the device meets those criteria:

Device: Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the specific tests (e.g., freedom from pinholes, physical properties, biocompatibility). It only indicates that the device "Meets" the specified ASTM and CFR standards.

The data provenance is not explicitly mentioned as retrospective or prospective, nor are country of origin of the data. The tests are described as being performed to meet international and US standards (ASTM, 21 CFR, ISO), which implies general laboratory testing rather than data collected from specific patient populations or geographical regions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For device testing of physical and chemical properties and biocompatibility, the "ground truth" is typically defined by the established testing protocols and acceptance limits within the referenced standards (e.g., ASTM D 5250-00e4, 21 CFR 800.20, ISO10993-10) rather than requiring expert consensus on individual results in the same way clinical image interpretation might. The tests are designed to be objective and measurable.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. For the type of objective physical and chemical testing performed for gloves, adjudication methods like 2+1 or 3+1 are typically not applicable. Results are against predefined criteria from standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging AI). This device is a medical glove, which is a physical barrier device, and its effectiveness is determined by its physical properties and biocompatibility, not by human interpretation or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable to the device. The device is a physical medical glove, not an algorithm or an AI-powered system. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective measurements and predefined criteria as established by recognized industry standards and regulations. Specifically:

• ASTM Standard D 5250-00e4: For Dimension, Physical Properties, and Powder Residual.
• 21 CFR 800.20: For Freedom from pinholes (which relates to the Acceptable Quality Level or AQL for water leak testing).
• ISO 10993-10: For Biocompatibility (Primary Skin Irritation and Dermal Sensitization).

These standards specify the methods of testing and the acceptance limits that define whether a glove "meets" the standard.

8. Sample Size for the Training Set

This information is not applicable and not provided. As a medical glove, the device does not employ machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons mentioned under point 8.

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