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A powdered 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 Nitrile Examination Gloves, Blue

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves, Blue". This document does not contain information about acceptance criteria and a study proving the device meets those criteria, as it pertains to a medical glove. The type of information requested (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is typically found in submissions for AI/ML-based medical devices or diagnostic tools, not for a physical device like examination gloves.

Therefore, I cannot fulfill your request based on the provided text.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance data for "Powdered Nitrile Examination Gloves" by SPI GLOVES SDN. BHD. This is a medical device and the information is presented as part of a 510(k) summary submitted to the FDA.

Here's a breakdown of the requested information:

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

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

• Sample Size: The document does not explicitly state the specific sample sizes used for each test. However, it indicates an AQL=2.5% for the watertight test, which implies a sampling plan based on statistical quality control standards like ISO 2859-1 (which ASTM D3578 references). For other tests (length, width, thickness, physical properties), a specific sample size is not provided.
• Data Provenance: The testing was performed by SPI GLOVES SDN. BHD., a company located in Ipoh, Perak, Malaysia. The data is likely prospective as it represents the performance data for the specific device manufactured by the submitter.

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)

This section is not applicable. The device is a physical product (examination gloves), and its performance is evaluated against established technical standards (ASTM D6319-00a53, FDA requirements) and laboratory tests, not through expert interpretation or clinical ground truth in the way medical imaging or diagnostic algorithms are. The "ground truth" is defined by these objective standards.

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

This section is not applicable. As explained above, the evaluation relies on objective measurements and compliance with technical standards and lab tests, not subjective interpretation requiring adjudication.

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 section is not applicable. This describes a physical product, not an AI-powered diagnostic or assistive tool for human readers.

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

This section is not applicable. This describes a physical product, not an algorithm.

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

The "ground truth" for this device's performance is established by objective technical standards and laboratory testing. Specifically:

• ASTM D6319-00a53 Standard
• FDA 1000 ml watertight test
• FDA minimum powder residual content
• Biocompatibility Tests (Primary Dermal Irritation Test and Guinea Pig Sensitization)

8. The sample size for the training set

This section is not applicable. This device is a manufactured product, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the same reason as point 8.

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Examination glove (Nitrile) is a disposable device made of Nitrile Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.

This document describes the performance and acceptance criteria for Shiva Medicare Limited's Powdered Nitrile Examination Gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., length, width, tensile strength). It refers to the "performance test data" but doesn't detail the sampling plan.

The data provenance is:

• Country of Origin: India (Shiva Medicare Limited is located in Chennai, India).
• Retrospective or Prospective: Not explicitly stated, but the tests were conducted on gloves manufactured by Shiva Medicare Limited to demonstrate compliance with ASTM D3578-95, suggesting these were contemporary tests on their product.

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

Not applicable. This is a technical performance study of a physical device (gloves), not a diagnostic device requiring expert interpretation of images or clinical data. The "ground truth" is defined by the objective measurement standards outlined in ASTM D3578-95.

4. Adjudication Method for the Test Set:

Not applicable, as this is a physical device performance study. The evaluation is based on direct measurement and adherence to the specified ASTM standard.

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, but a medical glove.

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. The device itself (the glove) is what's being evaluated, and its performance is measured directly against technical specifications.

7. The Type of Ground Truth Used:

The ground truth used is objective measurement against established industrial standards, specifically ASTM D3578-95 for examination gloves. These standards define the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and freedom from holes. For Powder, Protein, and Moisture content, specific SML values are provided with no direct ASTM D3578 comparative requirement stated in the table, implying these are internal specifications or generally accepted values. Biocompatibility is stated as "Biologically Compatible" without further detail on the specific tests or standards used, though it implies compliance with relevant biocompatibility testing.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device and does not involve AI or machine learning models that require training data.

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

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

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.

Powdered Nitrile Examination Gloves

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves." This document is a regulatory communication, not a scientific study report describing device performance or acceptance criteria in the typical sense of a clinical or performance study of an AI/software device.

Therefore, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) cannot be extracted from the provided text.

The document states that the device is "substantially equivalent" to predicate devices, meaning it has sufficiently similar characteristics and indications for use as a device already legally marketed. For examination gloves, the "performance" typically refers to physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from holes), which are usually tested against established international standards (like ASTM or ISO standards for medical gloves). The 510(k) process involves demonstrating compliance with these standards, but the detailed results of those tests are not typically included in the final clearance letter itself.

The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or human-AI improvement.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is concerned with the regulatory clearance of a physical medical device (examination gloves), not a software or AI-driven diagnostic or therapeutic device that would undergo the types of studies described in your prompt.

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A medical glove is worn on the hand of healthcare and similiar personnel to prevent contamination between healthcare personnel and patient

POWDERED NITRILE EXAMINATION GLOVES

This document is a 510(k) clearance letter from the FDA for Powdered Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a regulatory approval based on substantial equivalence to a predicate device, not a performance study report.

Therefore, I cannot provide the requested information based on the provided text. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Nitrile Examination Gloves (Blue Colour)

The provided document is an FDA 510(k) clearance letter for "Powdered Nitrile Examination Gloves (Blue Colour)." This type of document is a regulatory approval, not a technical report detailing performance criteria or a study. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device's performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates a regulatory comparison to a legally marketed predicate device, not a new performance study with specific acceptance criteria as you've outlined.

Therefore, I cannot provide the requested information from this document.

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A medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.

Powdered Nitrile Examination Gloves

This document is a 510(k) premarket notification from the FDA for Powdered Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving device performance as it is a regulatory clearance document rather than a performance study report.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Patient Nitrile Examination Gloves (Blue Colour)

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powdered Nitrile Examination Gloves (Blue Colour)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

**This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details for an AI/ML powered device. **

The letter is a regulatory approval for a physical medical device (gloves), not an AI/ML software device, and therefore the requested information is not applicable to its contents.

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