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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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a premarket notification for a medical device (Powder Free Vinyl Patient Examination Gloves, Colored (White)) and focuses on demonstrating substantial equivalence to a predicate device. It primarily relies on non-clinical testing to meet the acceptance criteria.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Size: Not explicitly stated for specific tests. The document indicates that the device "meets requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." These standards inherently require specific sample sizes for their respective tests, but the exact numbers used in this specific submission are not detailed.
   • Data Provenance: The manufacturing company is based in China: Hebei Handform Plastic Products Co.,Ltd., Julu County industrial park, Xingtai, Hebei Province, 055250, CHINA. It can be inferred that the testing was conducted to demonstrate compliance with these international standards, but the specific location of the testing laboratories is not specified. The study is prospective in the sense that these tests were conducted to demonstrate the device's properties before market entry for regulatory approval.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This question is not applicable to this type of device and study. The "ground truth" for glove performance is established by objective measurements and adherence to recognized standards (ASTM, CFR, ISO) rather than expert consensus on subjective interpretations like in imaging studies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • This question is not applicable to this type of device and study. Adjudication methods are typically used in clinical trials involving subjective endpoints or complex interpretations, not for objective material property testing.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of data, often with AI assistance. This device is a patient examination glove, so such a study would not be applicable.

5. 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 does not involve an algorithm. The "performance" here refers to the physical and biocompatibility characteristics of the glove itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • The "ground truth" for this device is based on objective measurements against established international and regulatory standards for material properties, dimensions, physical characteristics, freedom from defects, powder residue, and biocompatibility. These standards are themselves the "truth" against which the device's performance is measured.
     • 21 CFR 800.20: Freedom from pinholes (water leak test)
     • ASTM D 5250-06: Dimensions, Physical Properties
     • ASTM D6124-06: Powder Residual
     • ISO10993-10: Biocompatibility (Primary Skin Irritation and Dermal Sensitization)

7. The sample size for the training set

   • This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The product is a physical medical device (examination gloves).

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

   • This question 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to your requests:

Acceptance Criteria and Device Performance Study

The device reviewed is "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)" from Hebei Handform Plastic Products Co.,Ltd.

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 numerical sample size for the tests conducted to demonstrate compliance with ASTM standards, 21 CFR 800.20, and ISO10993-10.
The provenance of the data is implied to be from the manufacturer's testing (Hebei Handform Plastic Products Co.,Ltd. in China). The study is retrospective in the sense that the results are being reported after the tests were conducted, but it's not a retrospective analysis of existing clinical data. It is a report of non-clinical testing performed to establish safety and effectiveness.

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

Not applicable. The tests conducted (dimensional checks, physical properties, pinhole freedom, powder residual, and biocompatibility) are objective, laboratory-based tests that do not rely on expert interpretation for "ground truth" in the same way, for example, a medical imaging study would. The ground truth is defined by the objective measurements against established standards.

4. Adjudication method for the test set

Not applicable. As described above, the tests are objective measurements against predefined standards. There is no subjective interpretation that would require an adjudication method like 2+1 or 3+1.

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 device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

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

7. The type of ground truth used

The ground truth used for the acceptance criteria is based on established industry and regulatory standards:

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

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

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

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

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 is a 510(k) Premarket Notification summary for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the provided information, framed by your questions:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is for a medical device (patient examination gloves) that is subject to performance standards rather than requiring complex algorithmic analysis or human reader studies. Therefore, most of your requested points regarding AI/algorithm performance, ground truth establishment, and expert involvement are not applicable to this type of device and submission.

The "acceptance criteria" here refer to the performance requirements outlined in recognized standards (like ASTM and FDA regulations) for patient examination gloves. The "study" proving the device meets these criteria refers to non-clinical testing performed by the manufacturer.

1. A table of acceptance criteria and the reported device performance

Note: The powder amount in the "Device performance" column for "Biocompatibility" appears to be misplaced from "Powder Amount." I've corrected this in the table above based on the text. The Powder Amount test would yield a specific level, and the <10mg/dm² is under the biocompatibility section which is unusual. However, the document states "Powder Amount Meets" and then lists "<10mg/dm2" under the device performance for biocompatibility. I've attempted to align it to what seems most logical based on common glove testing.

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

The document explicitly states that "Clinical data is not needed for gloves or for most devices cleared by the 510(k) process."

Therefore, there is no "test set" in the context of clinical data or patient data. The tests performed are non-clinical, laboratory tests on the gloves themselves. The sample sizes for these specific non-clinical tests (e.g., number of gloves tested for pinholes, physical properties, or for biocompatibility testing on animals) are not provided in this summary.

Data provenance: Not applicable in the sense of country of origin for patient data or retrospective/prospective studies, as no human or patient data was used. The data comes from internal laboratory testing conducted by the manufacturer (Hebei Handform Plastic Products Co.,Ltd. in China) or a contracted lab.

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

Not applicable. There is no "test set" requiring ground truth established by experts in the context of this device and submission type. The ground truth is established by objective measurements against recognized industry standards (ASTM) and regulatory requirements (21 CFR).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication was required or performed for this type of non-clinical testing.

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 device is a physical product (gloves) and does not involve AI or human readers.

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

Not applicable. This device is a physical product and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance claims relies on objective measurements against established, recognized industry standards (ASTM D 5250-06, ASTM D6124-01) and FDA regulations (21 CFR 800.20) for glove characteristics, as well as biocompatibility testing according to standards like ISO10993-10.

8. The sample size for the training set

Not applicable. There is no algorithm or model that requires a training set for this device.

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

Not applicable. There is no algorithm or model that requires a training set for this device.

Ask a specific question about this device