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Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, as submitted in a 510(k) summary (K093570) to the FDA. The study presented a non-clinical evaluation to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

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 each characteristic. However, it indicates that the tests were performed according to specified ASTM and CFR standards, which would inherently include appropriate sample size requirements for those tests. The data provenance is not specified beyond the tests being conducted for the Jiangsu Jaysun Glove Co.,Ltd., located in China. The study is a non-clinical evaluation.

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

This section is not applicable as the device is a medical glove, and the evaluation involves objective performance testing against established physical and chemical standards, not expert interpretation of outputs like in imaging or diagnostic AI.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. The evaluation relies on objective measurements against predefined standards, not subjective assessment requiring adjudication.

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

This section is not applicable. The device is a medical glove, not an AI system. Therefore, an MRMC study and the concept of human readers improving with or without AI assistance are irrelevant.

6. Standalone (Algorithm Only) Performance Study

This section is not applicable. The device is a medical glove. The evaluation focuses on the physical and biological properties of the glove itself, not on an algorithm's performance.

7. Type of Ground Truth Used

The ground truth used for the device's performance evaluation is based on established industry and regulatory standards. These include:

• ASTM standard D 5250-06e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes, commonly referred to as the "waterleak test" for AQL)
• ASTM standard D 6124-06 (for powder residual)
• AAMI / ANSI / ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization)

These standards define the acceptable range or threshold for each characteristic.

8. Sample Size for the Training Set

This information is not applicable. The device is a medical glove, and its evaluation does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reasons as point 8.

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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 5250-004

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies for the device:

Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)
510(k) Number: K062520

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 tests to demonstrate compliance with the ASTM standards or 21 CFR 800.20. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.

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

This section is not applicable. The device is a medical glove, where "ground truth" typically refers to objective measurements and adherence to engineering standards rather than expert consensus on medical images or diagnoses. The "ground truth" here is the pass/fail result against established material properties and biocompatibility tests.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image analysis for disease detection. For device testing against objective standards, the results are typically binary (pass/fail) based on direct measurement.

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

No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on reader performance is evaluated. For a medical glove, this is not applicable.

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

This section is not applicable. The device is a physical product (a medical glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The performance evaluation focuses on the inherent physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on objective measurements against established national and international standards and regulations. Specifically:

• Physical and Dimension Properties: ASTM standard D 5250-00e4
• Freedom from Pinholes: 21 CFR 800.20
• Powder Amount: ASTM standard D 5250-00e4
• Biocompatibility: Primary Skin Irritation in rabbits (ISO10993-10) and Dermal sensitization in the guinea pig (ISO10993-10).

8. Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm or a diagnostic tool that requires a training set. The manufacturing process of gloves relies on established engineering and materials science principles, not machine learning.

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

This section 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 5250-00-4.

The provided text describes a submission for a medical device, specifically "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)," rather than a complex AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to studies of diagnostic accuracy, which are not performed for basic medical devices like gloves.

Here's an analysis based on the provided text for the aspects that are applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document for each test. The standards referenced (e.g., ASTM D5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10) specify sampling plans for testing, but the exact number of gloves tested for this specific submission is not provided.
• Data Provenance: Not explicitly stated. The testing was conducted by the manufacturer, JIANGSU JAYSUN GLOVE CO., LTD, which is based in China. The data would therefore be internal testing results generated by the manufacturer. It is prospective testing, as it's performed to demonstrate compliance of the manufactured product.

3. 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):

Not applicable. This device is a physical product (gloves), and performance is assessed against engineering standards and biocompatibility tests, not by expert interpretation or diagnosis for which "ground truth" established by human experts would be relevant.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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 is not an AI-powered diagnostic device.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the referenced International and National Standards (e.g., ASTM D 5250-00e4 for physical properties, 21 CFR 800.20 for freedom from pinholes, ASTM D6124-01 for powder residual, and ISO10993-10 for biocompatibility).

8. The sample size for the training set:

Not applicable. This device does not involve machine learning algorithms that require a "training set."

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

Not applicable. This device does not involve machine learning algorithms.

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