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The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).

The provided text describes the acceptance criteria and the study that proves a medical device (Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs) meets those criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed against ASTM standards and biocompatibility tests. The table below summarizes these, focusing on the key performance characteristics relevant to general surgical gloves and their resistance to chemotherapy drugs.

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The 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. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).

The document provided is a 510(k) Premarket Notification from the FDA for "Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically by adding a claim for fentanyl citrate permeation. It performs non-clinical testing to support this claim, rather than a study involving AI or human readers for diagnostic purposes.

Therefore, many of the requested details regarding AI device acceptance criteria, human reader studies, and AI-specific ground truth establishment are not applicable to this submission. This is a clearance for a physical medical device (gloves), not a diagnostic AI/ML device.

However, I can extract the relevant information regarding the device's acceptance criteria and the non-clinical study conducted to prove it meets those criteria.

Acceptance Criteria and Study for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

This medical device is a physical product (examination gloves), not an AI/ML diagnostic tool. The "acceptance criteria" here refer to the physical and chemical performance standards for the gloves, and the "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the re-submitted device (K232039) are based on relevant ASTM and ISO standards, and for chemotherapy and opioid drug permeation, specific minimum breakthrough times (BDT). The reported device performance indicates that the gloves passed all these criteria.

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

The document does not explicitly state the exact sample sizes used for each physical or chemical test. However, for tests like "Freedom from holes," it refers to AQL (Acceptable Quality Level) 2.5, which implies a sampling plan according to ASTM D5151-19. Similarly, other ASTM and ISO standards followed for physical properties and biocompatibility would specify sample sizes.

The data for these tests would be generated prospectively as part of product development and quality control for the submission. The country of origin for the data generation is implied to be China, given the manufacturer's location.

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

This concept is not applicable here. Ground truth in the context of this submission refers to the established standards and methodologies of the ASTM and ISO tests (e.g., how to measure tensile strength, how to test for permeation). These are standardized laboratory tests, not subjective expert interpretations of images or clinical outcomes. The "experts" are the laboratory personnel who perform these tests according to the published standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests have predefined, objective measurement protocols.

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 physical medical device (gloves), not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. There is no algorithm or AI component in this device. Performance is measured directly through bench testing.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective, standardized laboratory measurements against predefined performance specifications stated in ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. Specifically:

• Physical Properties: Measured values (e.g., length, width, thickness, tensile strength, elongation) are compared directly against minimum/maximum thresholds defined in ASTM D6319-19 and ASTM D412-16.
• Freedom from holes: Determined by water leak testing according to ASTM D5151-19, with acceptance based on AQL 2.5.
• Powder Residue: Quantified according to ASTM D6124-06 (2017) against a maximum limit.
• Chemical Permeation: Breakthrough Time (BDT) is measured for specific chemotherapy drugs and fentanyl citrate according to ASTM D6978-05 (2019) and compared against specified minimum times.
• Biocompatibility: Assessed through in-vitro/in-vivo tests for irritation, sensitization (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2017) to ensure no adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. As 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, as there is no training set for an AI/ML algorithm.

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This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05(Reapproved 2019).

Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable singleuse, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.

This document describes the premarket notification (510(k)) for a medical device – "Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs." This device is a Class I, reserved product, meaning it's subject to general controls but does not require extensive clinical data for approval if it demonstrates substantial equivalence to a legally marketed predicate device.

The provided text focuses on the device's technical specifications and non-clinical testing to demonstrate substantial equivalence to a predicate device, not on proving an AI algorithm's performance in a diagnostic context. Therefore, many of the requested elements for describing an AI acceptance criteria study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, effect size, standalone performance, training set details) are not applicable to this submission.

The "acceptance criteria" here refer to the product's physical, chemical, and performance standards as determined by established industry and regulatory test methods, not diagnostic performance metrics of an AI.

Here's an interpretation of the "acceptance criteria" and "study" based on the provided document:

Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through adherence to various ASTM and ISO standards. The acceptance criteria are the minimum or maximum values specified by these standards, and the reported device performance indicates whether the tested product met these thresholds.

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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 using ASTM D6978-05(2019)

Powder Free Polyurethane Examination Gloves, Blue color, tested for use with Chemotherapy Drugs are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L, XL and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).

The provided text describes the acceptance criteria and performance data for "Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs." This is a medical device, and the data pertains to its physical properties, biocompatibility, and resistance to chemotherapy drugs, all tested against established ASTM and ISO standards.

It is important to note that this device is a physical product (gloves) and not an AI/ML powered medical device. Therefore, many of the requested criteria (e.g., sample size for AI test/training sets, data provenance, expert adjudication, MRMC studies) are not applicable in this context. The information provided focuses on material science and medical device performance standards for physical safety and efficacy.

Here's a breakdown of the applicable information based on your request, along with an explanation for why certain criteria are not relevant:

Acceptance Criteria and Device Performance for "Powder Free Polyurethane Examination Gloves"

This device is not an AI/ML powered medical device. The acceptance criteria and performance are established through adherence to recognized international standards for medical examination gloves and specific testing for chemotherapy drug permeation.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation Data (from ASTM D6978-05 (2019) testing):

• Warning: Do not use with Carmustine or Thiotepa due to extremely low permeation times.

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

• Sample Size: The document does not explicitly state the sample size (number of gloves or test replicates) for each specific test (e.g., physical dimensions, watertightness, chemotherapy permeation). However, testing is performed in accordance with the methodologies described in the cited ASTM and ISO standards, which will specify appropriate sample sizes for validation.
• Data Provenance: The document indicates the manufacturer is "Grand Work Plastic Products Co., Ltd" with a China address (Donggao Industrial Zone, Zanhuang, Hebei, 050000, China). This implies the testing would have been conducted or overseen by the manufacturer, likely at their facilities or accredited contract labs. The data is retrospective, as it was collected as part of the premarket notification (510(k)) submission.

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

• Not Applicable. For a physical device like examination gloves, "ground truth" is established through standardized laboratory testing protocols (e.g., tensile strength, leak tests, chemical permeation) as defined by ASTM and ISO organizations. These tests yield objective, quantitative measurements rather than subjective expert interpretations. Therefore, there are no "experts" in the sense of human readers/annotators establishing ground truth for a test set. The "experts" involved are the scientists and engineers who developed and validated these international testing standards.

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

• Not Applicable. Adjudication methods are relevant for studies where subjective human interpretation or labeling is involved (e.g., medical image analysis, clinical assessments). For physical product testing, the results are typically quantitative and objective, and thus do not require an adjudication process.

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 physical medical device (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

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

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

• Ground Truth: The "ground truth" for this device's performance is established by the objective, quantitative measurements obtained through adherence to the specified ASTM and ISO standard test methods. These standards define the accepted methodologies for determining physical properties, biocompatibility, and chemical resistance. For example:
  • Physical properties (length, thickness, tensile strength, elongation): Measured directly using calibrated equipment according to ASTM D6319-19 and ASTM D412-16.
  • Watertightness: Determined by the "water leak test" (ASTM D5151-19) which is a pass/fail visual inspection after standardized water filling.
  • Powder Residue: Measured gravimetrically according to ASTM D6124-06.
  • Chemotherapy Drug Permeation (BDT): Determined by measuring the time it takes for a chemical to permeate the glove material using a detector, as per ASTM D6978-05.
  • Biocompatibility (Irritation, Sensitization, Cytotoxicity, Systemic Toxicity): Assessed through laboratory tests (e.g., cell cultures, animal models) conducted according to ISO 10993 standards, yielding specific biological responses.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device.

Summary of Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a compilation of non-clinical performance tests conducted in accordance with well-established international standards (ASTM and ISO). These tests systematically evaluate the physical properties, chemical resistance, and biocompatibility of the gloves.

The "Pass" results for each test (as shown in the table under "Non-Clinical Performance Data") demonstrate that the "Powder Free Polyurethane Examination Gloves" meet the pre-defined acceptance criteria for a Class I medical device of this type. The specifics of the testing (e.g., detailed methodology, equipment calibration, environmental controls) would be documented in the full test reports that support the 510(k) submission. The FDA's clearance (K222892) indicates that they have reviewed this data and found it sufficient to demonstrate substantial equivalence to legally marketed predicate devices, confirming the device's safety and effectiveness for its intended use. The critical warning regarding Carmustine and Thiotepa permeation times is a direct outcome of these tests and is vital for safe labeling and use.

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

Nitrile Vinvl Blend Powder Free Examination Gloves (Black) are Patient Examination Gloves. Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L and XL. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided text is a 510(k) premarket notification for Nitrile Vinyl Blend Powder Free Examination Gloves (Black). This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and does not involve AI or algorithms, human readers, or clinical performance data in the context of medical image analysis or similar diagnostic applications.

Therefore, many of the requested categories are not applicable to this type of device and submission. Based on the provided text, here's the relevant information:

1. Table of acceptance criteria and the reported device performance

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

• Freedom from holes: For each size (XS, S, M, L, XL), a sample size of 125 gloves was used.
• Powder-Content: Not explicitly stated, but results are given for each size.
• For other physical and biocompatibility tests, specific sample sizes are not detailed in the provided summary, but the tests were conducted.
• Data provenance: Not specified, but the product owner is Grand Work Plastic Products Co., Ltd. from China, suggesting the tests were likely conducted on products manufactured in China. The study is retrospective as it refers to completed tests.

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

This is not applicable. The device is an examination glove, and its performance is evaluated against established material and biocompatibility standards (e.g., ASTM, ISO), not by expert interpretation of clinical images or data requiring ground truth establishment by medical experts.

4. Adjudication method for the test set:

Not applicable, as this is for the evaluation of a physical medical device against a set of standards, not an AI or diagnostic algorithm requiring adjudication of interpretations.

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 submission is for a physical medical device (examination gloves), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used:

The "ground truth" for this device is derived from established international standards for physical properties (e.g., tensile strength, dimensions, freedom from holes, powder content) and biological safety (biocompatibility tests for irritation, sensitization, cytotoxicity, systemic toxicity). These standards define the acceptable range or criteria for the device's performance.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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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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 standards. Gloves is direct contact and not to be worn for more than 24 hours.

The subject device is Sterile Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs And Fentanyl Citrate (Blue). The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-11 and permeability to chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05(2019).

This document is a 510(k) premarket notification for "Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)". It details the device's characteristics, performance, and comparison to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is tested against various physical properties and chemical permeation criteria.

Physical Properties (based on ASTM D6319-19):

Chemotherapy Drug and Fentanyl Citrate Permeation (based on ASTM D6978 standards):

Note: For Carmustine and Thiotepa, the document explicitly states warnings due to low permeation times, even though they have a reported BDT.

Biocompatibility Studies (ISO 10993-10, ISO 10993-11, ISO 10993-5):

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

The document specifies the standards used for testing, which implicitly defines the sample sizes and testing methodologies. However, it does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for each chemotherapy drug).

• Standards Used: ASTM D6319-19 (for dimensions, physical properties, freedom from holes, powder content) and ASTM D6978-05(2019) (for permeability to chemotherapy drugs and Fentanyl Citrate). Biocompatibility testing was done per ISO 10993-10, ISO 10993-11, and ISO 10993-5.
• Data Provenance: Not explicitly stated, but based on the owner's identification (Grand Work Plastic Products Co., Ltd. in Hebei, China) and the contact information (Hongray USA Medical Products Inc. in Chino, California), the testing was likely conducted by or for the manufacturer, potentially in China or a contracted lab. The data is retrospective for the purpose of this 510(k) submission, as the tests have already been performed.

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

This question is not applicable as the document describes the testing of physical and chemical properties of gloves against established industry standards. The "ground truth" here is the performance requirement defined by these standards, not expert consensus on medical images or clinical outcomes. The tests are objective measurements, not subjective expert interpretations.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, quantitative measurements against predefined specifications (e.g., minimum length, minimum tensile strength, breakthrough detection time). There is no "adjudication" in the sense of reconciling differing expert opinions.

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 submission for sterile nitrile examination gloves, not an AI-powered diagnostic device. No human readers or AI assistance are involved in the performance evaluation of the gloves.

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

Not applicable. This is a physical medical device (gloves), not an algorithm.

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

The "ground truth" for the device's performance is objective, laboratory-measured data based on established international standards:

• Physical properties (dimensions, strength, elongation, hole detection, powder content) are measured quantitatively according to ASTM D6319-19, ASTM D5151-19, and ASTM D6124-06(2017).
• Chemical permeation (breakthrough detection time for chemotherapy drugs and Fentanyl Citrate) is measured according to ASTM D6978-05(2019).
• Biocompatibility (skin irritation, sensitization, systemic toxicity, cytotoxicity) is assessed using in vitro and in vivo tests guided by ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. This is a physical medical device, not a machine learning model.

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Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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 standards.

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).

The provided document is a 510(k) Premarket Notification from the FDA regarding Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs.

This document does not describe the acceptance criteria and study proving a software algorithm device meets these criteria, but rather the acceptance criteria and test results for a physical medical device (examination gloves).

Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device and the information provided in the 510(k) summary.

However, I can extract the relevant information about the acceptance criteria and the device's performance based on the provided document.

Device: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

Type of Device: Physical Medical Device (Examination Gloves), Class I, reserved

Study Purpose: To demonstrate substantial equivalence to a predicate device (Riverstone Resources SDN BHD. Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)) by verifying that the subject device meets specific performance standards and has similar technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several tables detailing the acceptance criteria (standards/specifications) and the results indicating that the device meets these criteria.

(Note: For chemotherapy drug permeation, the "Acceptance Criteria" are implied by comparison to the predicate device and showing equivalent or better performance. The exact criteria are not explicitly stated for each drug beyond the measured BDT.)

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "samples" in the way a software algorithm test set would be. The testing is based on batches of gloves or representative samples according to the referenced ASTM/ISO standards. For example, "Freedom from holes" testing follows an AQL (Acceptance Quality Limit) which implies a sampling plan.
• Data Provenance: The tests are non-clinical and conducted based on international standards (ASTM, ISO). The manufacturer is Grand Work Plastic Products Co., Ltd, located in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing would have been performed there or at certified labs used by the manufacturer. The data is retrospective in the sense that it was collected as part of the device's development and qualification prior to the 510(k) submission.

3. 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 this physical device's performance (e.g., tensile strength, breakthrough time) is established by adherence to standardized physical and chemical testing methods (ASTM, ISO standards), not by human expert consensus or clinical judgment in the traditional sense of diagnostic AI. These standards define the test procedures and acceptance limits.

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

Not applicable. This is not a study requiring human reader adjudication. Performance is measured by laboratory equipment and standard protocols.

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-based diagnostic device.

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

Not applicable. This is not an AI-based diagnostic device.

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

The "ground truth" is established through standardized physical, chemical, and biological testing methods as defined by:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06(2017) (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
• ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
• ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable. This is not a machine learning device.

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Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Vinyl Co-Polymer Powder-free Examination Gloves, Black are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.

The provided text is related to the FDA 510(k) premarket notification for "Vinyl Co-Polymer Powder-free Examination Gloves, Black". This document describes the device's technical specifications and how it compares to a predicate device. It also includes non-clinical performance data to demonstrate that the device meets established standards.

However, the request asks for specific information regarding acceptance criteria and a study proving a medical device meets those criteria, particularly in the context of AI/ML-assisted diagnostic tools (implied by questions about MRMC studies, human readers, ground truth establishment for training/test sets, etc.). The provided document is for examination gloves, which are Class I medical devices and do not involve AI, image analysis, or diagnostic capabilities in the way the questions are framed. Therefore, most of the requested information is not applicable to this submission.

I will fill in the relevant information that is present in the document and explicitly state when the requested information is not applicable due to the nature of the device.

Here's the breakdown based on the provided document:

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

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

The document refers to "non-clinical tests" and "performance test data" but does not specify the exact sample sizes (e.g., number of gloves tested for each individual parameter). The tests conducted are standard physical and biocompatibility tests for examination gloves as per ASTM and ISO standards.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the specifications of the referenced ASTM and ISO standards.
• Data Provenance: The manufacturing entity is Grand Work Plastic Products Co., Ltd in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing was presumably conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but for device development and regulatory submission, it would reflect tests performed on batches of the device.

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. This device is an examination glove, not an AI/ML-based diagnostic system that requires expert interpretation for ground truth establishment. The "ground truth" for these tests is based on objective physical, chemical, and biological measurements against established international standards (ASTM, ISO).

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

Not applicable. This is not an AI/ML diagnostic system requiring expert adjudication of results. Testing is based on laboratory measurements and adherence to specified tolerances.

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 device is an examination glove and does not involve human readers, AI assistance, or diagnostic interpretation.

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

Not applicable. This device is an examination glove and does not involve algorithms or standalone performance testing in the context of AI.

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

The "ground truth" for this device is based on:

• Physical and Mechanical Standards: Measurements of length, palm width, thickness, tensile strength, and elongation against specifications in ASTM D5250-19 and ASTM D412-16.
• Performance Standards: Freedom from holes (ASTM D5151-19, ASTM D65250-19) and powder content (ASTM D6124-06(2017), ASTM D5250-19).
• Biocompatibility Standards: Results from tests for skin irritation, sensitization (ISO 10993-10:2010), in vitro cytotoxicity (ISO 10993-5:2009), and acute systemic toxicity (ISO 10993 Part 11).

8. The sample size for the training set

Not applicable. This device is an examination glove and does not involve AI/ML models that require training sets.

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

Not applicable. As there is no training set for an AI/ML model, no ground truth establishment method for a training set is relevant.

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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.

Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

The provided document describes the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K142409) and seeks to prove its substantial equivalence to a predicate device (K061562). The study conducted is a non-clinical performance study comparing the subject device against the predicate device based on established standards and FDA requirements.

Here's the breakdown of the acceptance criteria and study details:

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 for Test Set: The sample sizes for each test are indicated by the "Inspection Level and AQL" or "N" values.
  • For physical dimensions (Overall Length, Width, Palm Thickness, Finger Thickness), Tensile Strength, and Ultimate Elongation: S-2, AQL4.0.
  • For Pinhole: G-I, AQL1.5.
  • For Residual Powder: N=5 (5 gloves tested).
  • For Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The specific number of samples (e.g., animals, human subjects, in-vitro replicates) is not explicitly stated, but the tests were performed "Under conditions of the study".
• Data Provenance: The study was conducted by Grand Work Plastic Products Co., Ltd., which is located in Zanhuang, Hebei, China. The data originates from this manufacturer. It is a prospective study as the tests were performed on the subject device to demonstrate compliance.

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 study is a physical and chemical performance test of a medical device (examination gloves), not an AI/clinical diagnostic device. Therefore, it does not involve experts establishing "ground truth" in the clinical sense (e.g., radiologists, pathologists). The "ground truth" is established by the pre-defined technical standards (e.g., ASTM D5250-06(2011), ISO 10993-10) and FDA requirements. The tests are performed by technicians in a laboratory setting according to specified protocols.

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

Not applicable. This is not a study involving human readers or clinical adjudication. The results are quantitative measurements or qualitative observations against a set 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 a performance study for a physical device (examination gloves), not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. This is a performance study for a physical device (examination gloves), not an algorithm or AI system.

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

The "ground truth" for this study is based on established industry standards and regulatory requirements. Specifically:

• ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
• ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).
• FDA requirements (e.g., for pinhole AQL).

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI study; there is no training set involved.

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

Not applicable. There is no training set.

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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.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

This is not a medical device that utilizes AI/ML. The provided text is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," which is a Class I medical device. Therefore, information related to AI/ML specific criteria such as multi-reader multi-case studies, effect size of human readers with AI assistance, standalone algorithm performance, or training set details is not applicable and cannot be extracted from this document.

However, I can provide the acceptance criteria and the studies that prove the device meets these criteria based on the provided text.

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." (Specific numerical sample size not provided, but AQL and inspection level are specified which determine the sample size. The data provenance is internal testing by the manufacturer.)
• FDA 1000 ml. Water Fill Test: "samplings of AQL 2.5, inspection level I." (Specific numerical sample size not provided, but AQL and inspection level are specified. The data provenance is internal testing by the manufacturer.)
• Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size for human or animal subjects used in these tests. The testing was conducted, implying it's a prospective study for the purpose of this submission.
• Residual Powder Test: The document does not specify the sample size. The data provenance is internal testing by the manufacturer.

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 (examination gloves), and the "ground truth" is established through standardized physical, chemical, and biological testing rather than expert-based interpretations.

4. Adjudication method for the test set

Not applicable. The testing methods for physical properties, pinholes, and biocompatibility are objective measurements against established standards, not subjective interpretations 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

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

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

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

• ASTM D-5250-06e1 (Standard Specification for Vinyl Patient Examination Gloves) for physical and dimensional properties.
• FDA 1000 ml. Water Fill Test for barrier integrity (pinholes).
• Primary Skin Irritation and Skin Sensitization testing for biocompatibility.
• ASTM D-6124-06 for Residual Powder.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or training set for this type of device. The "training" for manufacturing would involve adherence to quality control processes and standards.

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

Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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