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Powder Free Vinyl Patient Examination Gloves, Colored (White) 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.

This 510(k) summary describes the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (White) marketed by TANGSHAN HENGDA PLASTIC PRODUCTS 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 specific sample sizes used for each test. However, it indicates that the device "meets" the requirements of the specified ASTM standards and 21 CFR 800.20, which would imply that the sample sizes used for those tests were compliant with the respective standards. The data provenance is implied to be from laboratory testing conducted on the manufacturer's gloves to demonstrate compliance with the referenced standards. No specific country of origin for the data is mentioned, but the manufacturer is based in China. The data is retrospective, as it pertains to the evaluation of the finished product.

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

This information is not applicable. The product is a medical device (examination gloves) and the "ground truth" is established by performance metrics defined in regulatory standards (ASTM, FDA CFR) rather than expert interpretation of medical images or data. The "experts" in this context would be the technicians and scientists performing the tests according to the standard protocols. Their specific number and qualifications are not detailed in the summary but are assumed to be appropriate for conducting the tests against the established standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images) where there might be disagreement. For mechanical and biological performance testing of examination gloves, the outcome is determined by adherence to quantifiable metrics within the specified standards.

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

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, typically in diagnostic imaging or similar scenarios. As this device is an examination glove, such a study is not applicable.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" in that context is not applicable. The performance described here is the inherent physical and biocompatibility performance of the gloves themselves.

7. Type of Ground Truth Used:

The ground truth used is primarily established through regulatory standards and specifications. This includes:

• ASTM standard D 5250-06: for Dimension and Physical Properties.
• 21 CFR 800.20: for Freedom from pinholes (waterleak test/AQL).
• ASTM standard D 6124-06: for Powder Residual.
• ISO10993-10: for Biocompatibility (Primary Skin Irritation and Dermal sensitization).

These standards define the acceptable performance parameters that the device must meet.

8. Sample Size for the Training Set:

This information is not applicable. Training sets are used for machine learning algorithms. This device is a physical product, not an AI or algorithm, so there is no training set in this context.

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

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

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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow), 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.

The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)". This is a medical device and not an AI/ML powered device, therefore most of the requested information (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance) is not applicable or not found in the document.

Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable or not found:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to meeting standards (ASTM, FDA regulations for pinholes, ISO for biocompatibility tests), which typically involve specific sampling plans outlined in those standards, but the specific sample sizes used for this submission are not detailed.
• Data Provenance: Not explicitly stated. The testing was conducted to meet international and US standards. The submitter is from China, so the testing was likely conducted in or for the company in China, but this is an inference rather than explicitly stated. The studies are non-clinical, essentially laboratory-based testing of material properties, rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical product (gloves) and its performance is assessed against physical and chemical standards, not through expert interpretation of data.

4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, particularly in medical imaging or diagnostics, where multiple experts might disagree. This device's performance is objectively measured against established 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
Not applicable. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.

7. The type of ground truth used
The "ground truth" for this device's performance is defined by the objective metrics and thresholds established in the referenced standards:

• ASTM standard D 5250-06 for dimension, physical properties, and powder residual.
• 21 CFR 800.20 for freedom from pinholes (waterleak test on pinhole AQL).
• ASTM D6124-01 for powder residual.
• ISO10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization methods).

8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."

9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.

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