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Powder-Free Nitrile Examination 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 Glove

The provided text is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). It confirms the device's regulatory classification and that it has been deemed substantially equivalent to a predicate device. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of performance metrics that would typically apply to an AI/ML or diagnostic device.

The regulatory review for these gloves focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through adherence to established standards for examination gloves (e.g., physical properties, barrier integrity, biocompatibility). The document does not describe a performance study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be relevant to the questions posed.

Therefore, I cannot provide the requested information based on the input text. The questions asked are generally applicable to the validation of AI/ML-based medical devices or diagnostic tools, not to a Class I non-powdered patient examination glove.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs

The provided document describes the FDA clearance for "Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs" (K220155). This is a medical device, specifically examination gloves, and not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, are not applicable to this submission.

However, the document does contain information about the acceptance criteria and the study that proves the device meets those criteria for its intended use with chemotherapy drugs.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "WARNING: Not recommended for use with Carmustine and ThioTepa" due to their low permeation times. This indicates that while the testing was performed, the acceptance criteria for these specific drugs effectively resulted in a caveat for their use, highlighting that the "accepted" performance for other drugs is >240 minutes.

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

The document does not specify the sample size used for the test set (number of gloves or repetitions of testing). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in the full study report, which is not included in this FDA clearance letter.

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

Not applicable. This is a physical device (gloves) and its performance against chemical permeation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation. The "ground truth" is the chemical permeation itself, measured objectively.

4. Adjudication method for the test set

Not applicable. As this is not an AI/ML device, there's no "adjudication" in the sense of reconciling expert opinions on diagnoses or interpretations. The permeation testing follows a standardized protocol (ASTM D6978-05).

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/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance regarding chemotherapy drug permeation is established through objective laboratory testing following a recognized standard. Specifically, it used ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This standard defines the methodology to measure the breakthrough time of various chemotherapy drugs through the glove material.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of an algorithm.

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

Not applicable. As this is not an AI/ML device, there is no training set.

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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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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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05. Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs

The provided text describes the 510(k) premarket notification for "Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs" and includes information about the device's indications for use and performance related to chemotherapy drug permeation. Based on the document, I can extract the acceptance criteria and performance data for chemotherapy drug permeation. However, the document does NOT contain information about a study that would typically include details like sample size for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of an AI/algorithm-based device. This document is a regulatory submission for a physical medical glove, not an AI/software device.

Therefore, I will only be able to populate the acceptance criteria and device performance table, and explain why other requested information is not applicable to this document.

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For most drugs listed, the implied acceptance criterion is "greater than 240 minutes" of breakthrough detection time, as the device performance meets or exceeds this value for 12 out of 14 drugs. For Carmustine (BCNU) and Thiotepa, the document explicitly notes their "extremely low permeation time" and reports specific values (3.0 and 75.0 minutes, respectively). Therefore, the acceptance criteria for these specific drugs would be defined by the regulatory standard (ASTM D6978-05) and deemed acceptable given the specific performance measured.

Study Details (Information Not Applicable to this Document Type)

The provided document is a 510(k) clearance letter for a physical medical device (examination gloves). It describes the device's intended use and includes testing results for permeation by chemotherapy drugs, conducted in accordance with ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).

The questions you've asked (regarding sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set ground truth) are typically relevant for studies evaluating Artificial Intelligence (AI) or machine learning algorithms/devices.

Since this document pertains to a physical product (nitrile gloves) and its material properties, the concepts of "test set," "training set," "experts to establish ground truth," "adjudication method," "MRMC study," or "standalone (algorithm only) performance" are not applicable in this context. The "study" referenced is the physical permeation test conducted according to the ASTM standard, not a data-driven AI model evaluation.

Therefore, the requested details are not present in this document because they are not relevant to the type of device and evaluation described.

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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.

The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.

This device submission (K122696) is for Powder-Free Nitrile Examination Gloves (Cool Blue). It is a medical device designed to prevent contamination between patients and examiners. The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for patient examination gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

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 individual test (e.g., number of gloves tested for freedom from holes, number of animals for biocompatibility). However, it indicates that the tests were conducted according to recognized standards like ASTM D6319, ISO 10993-10, and 21 CFR 800.20. These standards typically define appropriate sampling plans and sample sizes for their respective tests.

The data provenance is retrospective, as the tests were conducted and summarized to demonstrate that the manufactured gloves meet the pre-defined performance standards. The country of origin of the data is not specified beyond where the testing facilities are located, which is also not detailed in the provided text.

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

This submission does not involve expert-established ground truth in the traditional sense of clinical studies. The "ground truth" for this device is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993-10, 21 CFR 800.20). These standards themselves were developed through expert consensus within their respective fields, but the submission itself does not detail the specific experts involved in the testing or analysis of the results. The determination of "meets requirements" is based on objective measurements against these standards.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements against pre-defined quantitative or qualitative criteria within the referenced standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1.

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 typically used for diagnostic or interpretive devices where human interpretation is a critical factor, often comparing human performance with and without AI assistance. This device is a medical glove, and its effectiveness is determined by objective physical and biocompatibility properties, not interpretive performance.

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

Yes, the studies presented are essentially standalone performance studies. The "device" in this context is the physical glove, and its performance is evaluated against material and physical specifications documented in the referenced standards (ASTM D6319, ISO 10993-10, etc.). There is no "algorithm" or "human-in-the-loop" component to the glove's function that would require a separate evaluation. The tests measure the intrinsic properties of the glove itself.

7. Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory requirements.

• Biocompatibility: Standards like ISO 10993-10 define acceptable levels of irritation and sensitization.
• Physical Characteristics: Standards like ASTM D6319 define acceptable dimensions, physical properties (e.g., tensile strength, elongation), freedom from holes (water leak test), and powder residual limits.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML-based device that requires a training set. The "device" is a physical product, and its performance is assessed through traditional engineering and material science testing methods, not through machine learning.

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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This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).

Nitrile rubber is impermeable to water and body fluids under normal conditions of use. The physical properties of the nitrile rubber enable it to conform to the hand for medical procedures. Nitrile rubber is known to form a superior barrier to bloodborne pathogens and meet physical properties for medical examination procedures as specified in ASTM D6319-00ae3.

This document is a 510(k) submission for Green Powder-Free Nitrile Examination Gloves, identifying K041276 as the submission number. The submission outlines the device's characteristics, intended use, and a comparison to a predicate device (K030207). It includes performance data from non-clinical tests to demonstrate safety and effectiveness.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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 for the non-clinical tests (e.g., number of gloves tested for freedom from holes or physical properties). Similarly, the country of origin for the data is not specified beyond the submitter's location in Shanghai, China. The studies described are non-clinical (laboratory testing), not human clinical trials, so the terms "retrospective" or "prospective" are not applicable in the typical sense for patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The ground truth for these non-clinical tests is established by adherence to recognized international and national standards (ASTM, FDA, ISO) and the results obtained from standardized testing methods. There is no mention of expert consensus establishing ground truth for these specific performance characteristics.

4. Adjudication Method:

Not applicable. This is not a study involving human readers or interpretations needing adjudication. The results are based on objective measurements and adherence to specified pass/fail criteria within the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved, which is not the case for examination gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in a sense, the tests performed are "standalone" in that they evaluate the physical and biological properties of the glove itself against established standards, without human interaction in a diagnostic or interpretive loop. The device's performance is determined solely by its material properties and manufacturing quality as measured by the specified tests.

7. The Type of Ground Truth Used:

The ground truth used for these tests is defined by:

• Established Standards: ASTM D6319-00ae3, ASTM D5151-99, ASTM D6124-01, FDA 21 CFR 800.20, and ISO 10993 Part 10. These standards set the criteria for acceptable performance (e.g., maximum allowable holes, maximum powder residue, minimum physical properties like tensile strength).
• Experimental Results: The outcome of the tests (e.g., whether the glove "Meets" the standard, or "Passes" irritation tests) constitutes the evidence against these standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a medical glove, and the evaluation is based on non-clinical performance testing. It does not involve AI algorithms that require training sets of data.

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

Not applicable, as no training set for an AI algorithm is involved.

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

This device is not intended to be used as a chemical barrier.

Textured Powder-Free Nitrile Examination Glove, Blue Color Tested for Use with Chemotherapy Drug

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, which is a Textured Powder-Free Nitrile Examination Glove. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.

The letter simply states that the FDA has reviewed the 510(k) submission and determined the device (the examination glove) is substantially equivalent to legally marketed predicate devices. This means it can proceed to market subject to general controls.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory approval process for a physical medical product, not on the performance evaluation of an AI-powered medical device through studies with specific acceptance criteria.

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Powder-Free Nitrile Exam Glove with Aloe Vera is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Powder-Free Nitrile Exam Gloves with Trade Name: Aloe Vera, Green Color

This document is a 510(k) clearance letter for Powder-Free Nitrile Examination Gloves. It does not contain information on acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information.

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