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The 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 and Fentanyl Citrate using ASTM D6978-05(2019)

Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided document describes the acceptance criteria and study results for the "Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K240080).

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are based on various physical characteristics, chemical permeation resistance (as per ASTM D6978-05(2019)), and biocompatibility tests (as per ISO 10993 standards). The reported device performance is compared to these criteria and, in some cases, to a predicate device (K200671).

Physical and Design Characteristics (Meeting ASTM D6319-19):

Chemotherapy Permeation Resistance (ASTM D6978-05(2019)):

Fentanyl Citrate Permeation Resistance (ASTM D6978-05(2019)):

Biocompatibility (ISO 10993 Standards):

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 specific sample sizes used for each test. However, it indicates that tests were conducted according to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs), and ISO 10993 series for biocompatibility. These standards typically specify the number of samples required for testing.

The data provenance is not explicitly stated as 'country of origin' in that format, but the applicant is "Syntex Healthcare Products Co., Ltd" from "Xinji, Hebei, China," indicating the testing likely occurred under their purview or by contracted labs. The studies appear to be prospective testing conducted specifically for this premarket notification.

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 information is not applicable as the document describes performance testing of a physical medical device (gloves) against established engineering and biocompatibility standards. It does not involve interpretation of medical images or patient data by human experts for ground truth establishment.

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

This information is not applicable for the same reason as point 3. Testing involves objective measurements against predefined 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

This information is not applicable as the device is a medical glove, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as the device is a medical glove, not an algorithm.

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

The "ground truth" for this device's performance is based on established international and national standards for medical gloves:

• ASTM D6319-19: for physical dimensions and integrity (e.g., freedom from holes, tensile strength).
• ASTM D6978-05(2019): for resistance to permeation by chemotherapy drugs and Fentanyl Citrate, where "breakthrough detection time" is the key metric.
• ISO 10993 series (ISO 10993-5, -10, -11, -23): for biocompatibility assessments like cytotoxicity, sensitization, irritation, and systemic toxicity.

8. The sample size for the training set

This information is not applicable as the device is a physical product and does not involve machine learning or AI models with training sets.

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

This information is not applicable as the device is a physical product and does not involve machine learning or AI models.

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The 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 and Fentanyl Citrate using ASTM D6978-05(2019)

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.

This document is a 510(k) summary for the Syntex Healthcare Products Co., Ltd.'s "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

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

The device's performance is primarily evaluated against recognized standards for medical examination gloves and specific tests for chemical permeation.

Note on Chemotherapy Permeation: For Carmustine and Thio Tepa, the reported breakthrough detection times (12.9 minutes and 35.6 minutes respectively) are explicitly noted as "extremely low permeation times" and a warning is issued: "Do not use with Carmustine and Thio Tepa." This indicates that for these specific drugs, the device does not meet an implicit "long duration" acceptance criterion and thus, limitations are clearly stated for safe use.

The study that proves the device meets (or defines limitations for) these criteria is a Summary of Non-Clinical Performance Data (Section 7 and 10 of the provided document).

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of gloves for physical dimensions, individual tests for chemotherapy permeation, or biological evaluations). However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes for testing to ensure statistical validity.

The data provenance is from Syntex Healthcare Products Co., Ltd., located at No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China. These are retrospective tests conducted by the manufacturer as part of the premarket notification (510(k)) submission process.

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

This information is not provided in the document. For non-clinical performance data like material testing and chemical permeation, "experts" in the sense of clinical decision-makers (e.g., radiologists) are not typically involved in establishing ground truth. The ground truth is objective, defined by the parameters of the test methods (e.g., measuring glove dimensions, detecting chemical breakthrough, evaluating cellular response). The tests are performed by personnel trained in the specific methodologies, likely in a laboratory setting.

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

An adjudication method (like 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, often when establishing a ground truth from multiple reviewers. Since these are non-clinical laboratory tests with objectively measurable outcomes (e.g., min/mm measurements, detection of chemical permeation, biological response), an adjudication method is not applicable and therefore, none was used. The "ground truth" is determined by the direct results of the standardized tests.

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:

No MRMC comparative effectiveness study was done. This type of study is completely irrelevant for a medical device such as examination gloves, which do not involve human readers or AI assistance in their function or evaluation.

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

No standalone algorithm-only performance assessment was done. This device is an examination glove, not an AI or software-based medical device.

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

The ground truth for the non-clinical tests is based on objective measurements and observations according to established ASTM and ISO standards and methodologies.

• Physical properties and dimensions: Direct physical measurements.
• Chemical permeation: Detection of the breakthrough of specific chemicals through the glove material using analytical methods defined in ASTM D6978-05 (2019).
• Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) tests with defined endpoints and criteria.
• Bioburden: Microbiological testing to quantify microorganism levels.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning device, so there is no "training set." The data presented is from non-clinical performance testing of the final product.

9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply here.

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A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

The provided documents describe the performance of "Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink". This is a medical device classified as a Class I, 21 CFR 880.6250, Polymer Patient Examination Glove, 80 LZA.

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

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

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

The document does not specify exact sample sizes for each test. However, the tests are non-clinical (laboratory/material characteristic tests) and typically involve statistical sampling based on the specific ASTM or ISO standard requirements for batch testing. The data provenance is implied to be from the manufacturer's testing in support of their 510(k) submission, likely performed in China (country of origin of the manufacturer) and provided to the FDA. The tests are retrospective, meaning they were conducted on already manufactured devices.

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

This information is not applicable as the evaluation of exam gloves against ASTM and ISO standards involves objective laboratory measurements and tests, not subjective interpretation by human experts to establish ground truth. The "ground truth" is the established technical specification defined by the standards themselves.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process of resolving discrepancies among multiple human readers for subjective assessments (e.g., medical image interpretation). For the physical and chemical tests conducted on examination gloves, the results are quantitative or qualitative assessments against defined criteria, not 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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a disposable examination glove, not an AI diagnostic tool.

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

A standalone performance study was not done. This question is also relevant for AI algorithms. The performance of the examination glove is measured by its physical and chemical properties and biocompatibility, not by an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by conformance to recognized industry standards (ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3). These standards define the acceptable range or limits for dimensions, strength, freedom from holes, residual powder, and biological response (skin irritation/sensitization).

8. The sample size for the training set

This information is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

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

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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

The provided text describes a 510(k) premarket notification for "Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". This is a medical device approval application, not a study of an AI/ML device. Therefore, the specific questions related to AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable.

However, I can extract the acceptance criteria and performance data for this device as it relates to the non-clinical tests conducted.

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

The acceptance criteria are generally established by recognized standards like ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, and 16CFR 1500.41/1500.3. The "Performance Results" column indicates if the device meets these standards.

Breakthrough Detection Times (BDT) for Chemotherapy Drugs (Resistance to Permeation):

Important Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes." This implies that while the device was tested against these drugs, their low BDTs are a critical factor for users to consider, and the labeling states "Do not use with Carmustine and Thiotepa."

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 non-clinical test (e.g., how many gloves were tested for dimensions, physical properties, or permeation). It mentions the tests were performed by Syntex Healthcare Products Co., Ltd in China (the submitter's location), so the data likely originates from China. The tests are non-clinical and would be considered prospective for the purpose of the 510(k) submission.

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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are designed for AI/ML device evaluations. The presented document describes a traditional medical device (examination gloves) and its non-clinical testing. Therefore, these questions are not applicable to this submission. The "ground truth" for this device is determined by physical and chemical testing against established standards (e.g., ASTM standards for glove properties and permeation resistance). No AI/ML components are mentioned or evaluated in this 510(k) summary.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00€3

This document describes the validation of a medical device, specifically a "Powder Free Nitrile Blue Textured Examination Glove." However, it focuses on the physical and biological characteristics of the glove and its substantial equivalence to a predicate device, rather than the performance of an AI or software-based medical device.

Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device submission.

Here's the information that can be extracted and presented, with clarifications for the questions that don't apply:

Acceptance Criteria and Reported Device Performance

Study Details (as applicable for a physical medical glove)

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

   • Sample Size: Not explicitly stated as a single "test set" for performance evaluation in the way a software algorithm would be. Instead, testing was conducted on samples from manufacturing lots based on AQLs (Acceptable Quality Levels).
     • Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
     • Water Fill Test: AQL 2.5, inspection level G-1.
   • Data Provenance: Not specified, but generally, such testing would be conducted by the manufacturer (Syntex Healthcare Products Co., Ltd.) in China, where the device is manufactured. The testing is likely retrospective in the sense that it's performed on finished products, but it represents ongoing quality control.

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

   • Not Applicable. The "ground truth" for a physical glove is determined by established physical and chemical test methods against defined standards (ASTM, FDA). It does not involve expert consensus in the way an AI diagnostic tool would for clinical images.

3. Adjudication method for the test set:

   • Not Applicable. Pertains to expert review for ambiguous cases in diagnostic studies, not physical product testing.

4. 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 physical, disposable medical device, not an AI software.

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

   • Not Applicable. This is a physical, disposable medical device, not an AI algorithm.

6. The type of ground truth used:

   • Established Standards and Test Methods: The ground truth for this device's performance is based on recognized consensus standards (ASTM D-6319-00€3, ASTM D-6124-01) and regulatory test methods (FDA 1000 ml. Water Fill Test), as well as biocompatibility testing for skin irritation and sensitization.

7. The sample size for the training set:

   • Not Applicable. This refers to machine learning algorithms, which are not involved here.

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

   • Not Applicable. As above, no training set for an AI algorithm.

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A 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.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.

The provided text is a 510(k) summary for a medical device: "Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy." Based on the provided document, the device is a Class I patient examination glove. The document describes non-clinical tests to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (This refers to a sampling plan for quality control rather than a specific sample size for a "test set" in an AI/Software context).
• FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level G-1. (Again, a sampling plan for quality control).
• Biocompatibility (Skin Irritation/Sensitization), Residual Powder Test: No specific sample sizes are mentioned for these tests, only that testing was "conducted."
• Data Provenance: Not applicable in the context of this device (a physical glove). The tests are performed on manufactured gloves.

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

This information is not applicable to this type of device (a physical examination glove). Ground truth in this context is established by physical measurements and laboratory analyses against defined standards, not by expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessment.

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 information is not applicable to this type of device. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI for assistance. This device is a physical glove.

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

This information is not applicable to this type of device. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a physical glove.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on defined physical and chemical standards as outlined in relevant ASTM standards and FDA requirements. This includes:

• Physical dimensions and tensile strength (ASTM-D-6319-00aE3)
• Barrier integrity (FDA 1000 ml. Water Fill Test for pinholes)
• Biocompatibility (Primary Skin irritation and Skin Sensitization testing via laboratory methods)
• Powder content (ASTM D6124-01)
• (Implied: Chemotherapy permeation data based on the device name, but methods/results are not detailed in this summary).

8. The Sample Size for the Training Set

This information is not applicable to this type of device. Training sets are relevant for machine learning algorithms, not for physical products like gloves.

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

This information is not applicable to this type of device, as it does not involve a training set for an algorithm.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

Ultrasense AF Blue Power-free Nitrile Examination Gloves

This document pertains to the clearance of "Ultrasense AF Blue Power-Free Nitrile Examination Gloves" (K033777). As such, it is a device submission for a physical product (gloves), not a diagnostic AI/ML algorithm or software as a medical device (SaMD).

Therefore, the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and sample sizes for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence determination for examination gloves based on regulatory requirements for a physical medical device, not a software-based diagnostic tool.

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A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove 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.

Syntex Powder-Free Latex Examination Gloves - Blue Color. A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder.

The provided text is a scanned FDA 510(k) clearance letter for "Syntex Powder-Free Latex Examination Gloves". This document pertains to the regulatory clearance of a medical device based on substantial equivalence to a predicate device, rather than a study proving performance against specific acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or information about training sets for an AI/algorithm-based device.

The questions are designed for a scenario where an AI or algorithm-based device undergoes performance evaluation and validation, which is not the subject of this 510(k) clearance for a physical medical product like examination gloves.

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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.

Powder-Free Nitrile Examination Glove -- Purple Color

The provided document is a 510(k) clearance letter from the FDA for a device called "Syntex Powder-Free Nitrile Examination Glove, Purple Color." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI or comparative effectiveness studies.

The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device already on the market, based on its indications for use, technological characteristics, and performance data. However, the performance data itself, including specific acceptance criteria and study results, is typically found in the 510(k) submission summary, which is not part of this letter.

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

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A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Pre-Powdered Nitirile Examination Glove

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The text provided is an FDA clearance letter for a medical device (Syntex Pre-Powdered Nitrile Examination Glove), outlining its substantial equivalence to a predicate device and regulatory compliance. It does not contain details about specific performance metrics or studies.

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