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Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Orange are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile latex and are powder free. They are ambidextrous. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document is a 510(k) summary for the Powder Free Nitrile Examination Gloves, Orange, and it describes a non-clinical study to demonstrate substantial equivalence to a predicate device, not a study to prove the device meets acceptance criteria for a new medical device technology. Therefore, many of the requested elements for a study proving device performance (e.g., sample size for test set, ground truth, MRMC study, training set information) are not applicable or not provided in the context of this regulatory submission.

However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted to support the device's substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests):

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

• Test Set Sample Size: The document does not specify the exact sample sizes (number of gloves or tests) for each non-clinical test conducted. It only reports the ranges of performance achieved.
• Data Provenance: The data is from non-clinical tests performed by Shanxi Hongjin Plastic Technology Co., Ltd. for their device Powder Free Nitrile Examination Gloves, Orange. The type of data is laboratory test results. No country of origin for the data is explicitly stated beyond the manufacturing company's location in China. The tests are prospective in the sense that they were conducted for this specific device to meet regulatory requirements.

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. These are non-clinical material and performance tests, not clinical studies requiring expert ground truth for interpretation of medical data. The "ground truth" is defined by the technical specifications and standards (e.g., ASTM, ISO).

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

• Not applicable. This is not a clinical study involving human readers or adjudicators for diagnosis. The tests are objective measurements against defined 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-assisted device, nor a comparative effectiveness study involving human readers.

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 these tests is based on established industry standards (ASTM D6319-19, ASTM D412-16, ASTM D5151-19, ASTM D6124-06(2017)) and international biocompatibility standards (ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2017). These standards specify the test methods and the acceptable ranges for the physical, chemical, and biological properties of examination gloves.

8. The sample size for the training set:

• Not applicable. This device 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:

• Not applicable. As above, this does not involve a training set for an algorithm.

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The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) summary for "Powder Free Nitrile Examination Gloves (Orange)". This document outlines the device's characteristics and compares them to a predicate device to establish substantial equivalence, which is a regulatory pathway for medical devices. It does not describe a clinical study in the typical sense of evaluating the effectiveness or safety of a new medical treatment or diagnostic algorithm.

Instead, the document details non-clinical performance data to demonstrate that the new device (Powder Free Nitrile Examination Gloves (Orange)) meets established standards and performs similarly to a legally marketed predicate device (Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, K140418).

Here's an analysis of the requested information based on the provided text:

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

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, physical properties, or watertightness). However, the tests are performed according to recognized standards (ASTM, ISO, CFR), which typically specify appropriate sampling plans.

• Data Provenance: The manufacturer is "Comfort Rubber Gloves Industries Sdn. Bhd." located in Matang, Perak, Malaysia. The testing would have been conducted by or for this manufacturer. The data is prospective in the sense that these tests are performed on the manufactured product to ensure it meets the specified standards.

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 is not applicable to this type of device and study. The "ground truth" here is objective physical and chemical properties measured against established industry standards (ASTM, ISO, CFR). It does not involve expert interpretation or clinical judgment.

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

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The tests involve objective measurements and pass/fail criteria based on defined 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 a 510(k) submission for examination gloves, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI integration, or assessment of human reader improvement is relevant or performed.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests are established, objective performance standards and specifications documented in:

• ASTM D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D6124-06 (2011) - Standard Test Method for Residual Powder on Medical Gloves
• ISO 10993-10:2010 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
• 21 CFR 800.20 - Medical device general controls
• ASTM D5151 - Standard Test Method for Detection of Pinholes in Medical Gloves by Visual Inspection of the Inflated Glove

These standards define the acceptable range or threshold for physical properties (length, tensile strength, elongation, thickness), chemical properties (powder content), biological reactions (biocompatibility), and integrity (watertightness).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. The gloves are manufactured and then tested against established standards.

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

Not applicable for the same reason as point 8. The standards themselves are developed through industry consensus, scientific research, and regulatory requirements, not through a "training set" for an algorithm.

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A powder-free 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 Nitrile Examination Gloves, Orange Color

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving that a device meets such criteria.

The document is an FDA 510(k) clearance letter for "Powder-Free Nitrile Examination Gloves, Orange Color" (K141021). This letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new Premarket Approval Application (PMA).

The letter primarily focuses on:

• The trade/device name and regulation information.
• The substantial equivalence determination.
• General controls and regulations applicable to the device.
• Contact information for FDA guidance.
• The "Indications for Use" for the gloves, which defines their intended medical purpose.

There are no details about:

• Specific performance acceptance criteria for the gloves (e.g., tensile strength, puncture resistance, barrier integrity metrics).
• Any study (clinical or non-clinical) that was conducted to demonstrate performance against such criteria.
• Sample sizes for test or training sets.
• Ground truth establishment, experts, or adjudication methods.
• MRMC studies or standalone algorithm performance, as these gloves are a physical medical device, not an AI or software device.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Orange Scented, Orange Powder Free Nitrile Examination Gloves, Vanilla Scented, White

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." This document announces the substantial equivalence of the device to legally marketed predicate devices.

It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts), MRMC studies, standalone performance, or training set information for an AI/ML device. The letter pertains to a simple medical device (gloves) and not an AI/ML system.

Therefore, I cannot provide the requested information based on the input document.

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Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.

Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange)

The provided text is a 510(k) premarket notification letter from the FDA to Brightway Holdings Sdn. Bhd. for "Brightway Brand Colored Powder Free Nitrile Examination Gloves, Orange". This document approves the device for market based on substantial equivalence to a predicate device.

It does NOT contain the type of acceptance criteria, study details, or performance data typically found for AI/ML-based medical devices. The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA) or extensive clinical trials as would be the case for novel AI.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This information is simply not present in the provided text.

The document discusses regulatory classification (Class I), general controls, and compliance requirements, but not the technical performance metrics of the gloves themselves.

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