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A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

This is a disposable natural rubber surgical glove that is tested for use with chemotherapy drugs and fentanyl resistance. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9.

The provided document describes the acceptance criteria and study results for two types of Natural Rubber Latex Surgical Gloves:

1. Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
2. Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

This is a 510(k) Premarket Notification submission, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The information provided focuses on the performance of the device against established standards (e.g., ASTM standards) rather than a clinical trial with human subjects or an AI-based study. As such, many of the requested points related to AI/MRMC studies, expert ground truth establishment, adjudication methods, and training/test set sample sizes for AI are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The "Summary of Non-Clinical Testing" (pages 15-16) and "Table 1" (pages 8-14) present the acceptance criteria and the device's performance.

Summary Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not explicitly state the specific number of gloves (sample size) used for each physical, chemical, and biocompatibility test. It refers to compliance with ASTM standards, which typically specify minimum sample sizes for testing (e.g., ASTM D5151 for watertightness requires a specific inspection level and AQL, implying a certain sample size based on lot size). However, the exact sample numbers are not itemized here.
• Data Provenance: The tests are non-clinical (laboratory tests) performed on the manufactured gloves. The manufacturer is WRP Asia Pacific Sdn. Bhd., located in Malaysia (as per Section 1.0 Submitter). The data is generated from testing of the finished device. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission, validating the device's properties.

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

• Not Applicable. This is a medical device submission based on a laboratory evaluation against recognized performance standards (ASTM, ISO, CFR). The "ground truth" for the device's physical and chemical properties is established by these objective, standardized test methods and their defined acceptance criteria, not by human expert interpretation or consensus as would be the case for an AI-enabled diagnostic device.

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are objective, laboratory-based measurements (e.g., tensile strength, breakthrough time, watertightness), there is no need for expert adjudication. The results are quantitative and compared directly to predetermined numerical acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on that interpretation. This submission is for a physical barrier device (surgical gloves), not an AI-enabled diagnostic tool.

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

• Not Applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Ground Truth: The ground truth for this device is established by objective, standardized test methods and their defined acceptance criteria. These standards (e.g., ASTM D3577, ASTM D6978-05, ISO 10993 series) specify a methodology for testing and a quantitative or qualitative result that the device must meet (e.g., minimum tensile strength, maximum protein content, no breakthrough of chemicals). The chemical permeation results are based on the ASTM D6978-05 standard for chemotherapy drug permeation.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The glove is a manufactured product whose performance is evaluated against material and safety standards.

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

• Not Applicable. Since there is no training set, this question is not relevant.

Ask a specific question about this device

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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19. The powder free examination glove is manufactured from synthetic rubber nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile. The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.

The provided text describes the acceptance criteria and performance of "Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl". This is a medical device, specifically examination gloves, and therefore the "study" concerns non-clinical performance testing rather than studies involving human participants or AI algorithms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• For Watertightness (ASTM D5151):
  • Small: 200 pcs
  • Medium: 315 pcs
  • Large: 315 pcs
  • Extra Large: 315 pcs
  • Double Extra Large: 200 pcs
• For other tests (Physical Properties, Dimension, Residual Powder, Biocompatibility, Chemotherapy Drug and Fentanyl Citrate Permeation): The specific sample sizes are not explicitly stated in the provided text. However, for these types of non-clinical tests, samples are typically drawn from manufacturing lots according to the requirements of the respective ASTM or ISO standards.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is a report of completed non-clinical performance and safety testing.

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. The document describes the performance of a physical medical device (gloves) through standardized non-clinical laboratory testing (e.g., tensile strength, chemical permeation) to establish its physical and chemical properties and safety. There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes for this type of device.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices or AI algorithms, to resolve discrepancies in human expert interpretations or to establish a consensus ground truth. This document pertains to non-clinical laboratory testing of a tangible product.

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 is not applicable. The device is a physical examination glove, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and there is no AI assistance involved.

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

This is not applicable. The device is a physical examination glove, not an algorithm, so there is no standalone algorithm performance to evaluate.

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

The "ground truth" for this device's performance is established by the accepted methodologies and metrics defined in the referenced ASTM and ISO standards for physical, chemical, and biocompatibility testing. For example:

• Physical properties (tensile strength, elongation) are measured objectively using a Tensile Testing Machine.
• Dimension (length, width, thickness) is measured using appropriate measurement tools.
• Watertightness is determined objectively by inspecting for holes after filling with water.
• Chemical permeation is physically measured based on the detection time of breakthrough.
• Biocompatibility is assessed through standardized in-vitro or in-vivo (animal) tests specified by ISO 10993 standards.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense of a diagnostic or therapeutic device for this type of product.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning model, so there is no training set.

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

This is not applicable as there is no training set for a physical product.

Ask a specific question about this device

A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. (Table of chemotherapy drugs and breakthrough times) Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes

This is a disposable polyisoprene surqical glove that is tested for use with chemotherapy drugs and fentanyl. The device is composed of two layers which are not attached in the fingers or palm/back of hand region, but are attached in the cuff area. The outer layer of the glove is white and the inner layer is green. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 81/2 and 9, and is provided sterile. No shelf life is claimed.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This document is a 510(k) premarket notification for a medical device (surgical gloves), which primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device. Therefore, many of the questions related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable (N/A) in this context.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many gloves were tested for tensile strength or dimensional analysis). It refers to standard test methods (e.g., ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11, ASTM D6978-05), which inherently define the required sample sizes for conducting those tests to achieve statistically valid results according to their respective standards. The data provenance is Malaysia, as the submitter (WRP Asia Pacific Sdn. Bhd.) is located in Malaysia. The testing is retrospective, conducted specifically for this submission.

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

N/A. This device's performance is established through objective, standardized physical and chemical testing, not expert interpretation of cases or images.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers, where there's subjectivity in interpretation. This is not relevant for the objective physical and chemical tests performed on the surgical gloves.

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

N/A. This is not an AI-assisted device. The device itself is a surgical glove.

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

N/A. This is not an algorithm or AI-based device.

7. The type of ground truth used

The "ground truth" for the performance of the surgical gloves is established by objective measurements against established industry standards and regulatory requirements. For example:

• Physical Properties: Measured tensile strength, elongation, and stress values are compared against minimum/maximum thresholds defined by ASTM D3577 and D412.
• Dimensions: Measured lengths, widths, and thicknesses are compared against specified ASTM D3577 requirements for each glove size.
• Watertightness: The number of detected holes is compared against the Acceptable Quality Limit (AQL) of 1.5 as per ASTM D5151 and D3577.
• Residual Powder: The measured powder residue is compared against the limit of ≤2.0 mg/glove as per ASTM D6124 and D3577.
• Biocompatibility: Biological responses (irritation, sensitization, systemic toxicity, pyrogenicity) are evaluated against the criteria for "Pass" as defined by ISO 10993-10 and ISO 10993-11.
• Chemotherapy Drug Permeation and Fentanyl Resistance: The breakthrough detection times are measured according to ASTM D6978 and compared against established timeframes.

8. The sample size for the training set

N/A. This is not an AI/machine learning device that requires a training set.

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

N/A. Not applicable as there is no training set for this device.

Ask a specific question about this device

A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate.

Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460. The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use. The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.

The provided text describes the acceptance criteria and performance data for a medical device (Polyisoprene Surgical Glove) in the context of an FDA 510(k) submission. It focuses on the device's physical properties, safety (biocompatibility), and resistance to chemotherapy drugs and fentanyl. This is a medical device, not an AI/ML device, so many of the requested elements for AI/ML performance studies (e.g., sample size for test/training sets, expert ground truth, MRMC studies, effect size, etc.) are not applicable or present in this document.

However, I can extract the acceptance criteria and device performance based on the non-clinical testing sections provided.

Here's a breakdown of the available information:

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

The document provides extensive tables (Table 1, starting on page 7, and the "Summary of Non-Clinical Testing" tables starting on page 16) detailing the characteristics, standards, acceptance criteria, and device performance. I will consolidate the key acceptance criteria and reported performance from these tables.

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

• Sample Size for Test Set:
  • For the Watertight test (ASTM D5151), the sample size was 125 pieces.
  • For other physical and material tests (e.g., Physical Properties, Dimension, Residual Powder, Biocompatibility), specific sample sizes are not explicitly stated in the provided text, but testing standards (e.g., ASTM D412, D3767, D6124, ISO 10993 series) would prescribe minimum sample sizes for these tests.
  • For Chemotherapy Drug and Fentanyl Permeation, the ASTM D6978 standard would specify the number of samples required, but this is not detailed in the document.
• Data Provenance: The testing was conducted as part of a 510(k) submission for a device manufactured by WRP Asia Pacific Sdn. Bhd. (Malaysia). The tests themselves are non-clinical, laboratory-based tests adhering to international and ASTM standards. The data is thus prospective, generated specifically for this submission.

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 medical device (glove) filing, not an AI/ML device requiring human expert annotation or ground truth establishment in the traditional sense. The "ground truth" for the device's performance is established by the results of standardized physical, chemical, and biological tests, not by human expert interpretation.

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

• Not Applicable. As this is not an AI/ML study involving human interpretation of data where adjudication is needed, no such method was employed. The results are quantitative measurements against established test 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:

• No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed. The device is a physical barrier (surgical glove).

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

• Not Applicable. This device is a physical product (glove), not an algorithm or AI. Its performance is inherent to its material and manufacturing, tested against physical and chemical standards.

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

• The "ground truth" for this device's performance is based on objective measurements and chemical/physical analyses performed according to established and recognized international standards (ASTM, ISO). For example:
  • Tensile strength (measured in MPa, physical property).
  • Elongation (measured in %, physical property).
  • Dimensions (measured in mm, physical property).
  • Detection of holes (binary, based on water leakage).
  • Residual powder (measured in mg/glove, chemical analysis).
  • Permeation breakthrough time (measured in minutes, chemical analysis).
  • Biocompatibility tests (evaluating biological reactions based on validated assays).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so 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 model, there is no ground truth to establish for it.

Ask a specific question about this device

A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.

The provided text is a 510(k) premarket notification for a medical device: "Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies often associated with AI/ML devices. Therefore, the questions related to AI/ML device testing (e.g., ground truth establishment by experts, MRMC studies, training set details) are not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the physical characteristics of the examination gloves, which are the relevant "performance" metrics for this device.

Here's the information based on the provided text, focusing on the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties: Data is provided for each size (XS, S, M, L, XL). The specific sample size for each test (e.g., number of gloves tested for tensile strength) is not explicitly stated, but the results represent the performance across these sizes.
• Dimension: Data is provided for each size (XS, S, M, L, XL).
• Watertight:
  • XS & XL: Sample size 200 pcs each.
  • S, M, L: Sample size 500 pcs each.
  • Data Provenance: The document does not specify the country of origin where the testing was conducted or if it was retrospective/prospective. It's non-clinical lab testing.
• Residual Powder: Sample size: 5 pcs.
• Extractable Protein Content: Sample size: 3 pcs.

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

Not applicable. This device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not clinical expert review of images or medical data. The "ground truth" is defined by the parameters of the ASTM standards and the test results.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against predefined standards, not subjective assessments requiring multiple reviewers or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is not an AI/ML device or a diagnostic device that would typically undergo MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

The ground truth is established by international and national standards (e.g., ASTM D3578, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ASTM D5712-99, ISO 10993 series) for physical properties, biocompatibility, and manufacturing quality of medical gloves. These standards define the measurable acceptance criteria.

8. The Sample Size for the Training Set

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

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

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

Summary of Study Type:

The document describes non-clinical performance testing against established industry standards (ASTM, ISO) to demonstrate that the Natural Rubber Latex Examination Glove meets all relevant safety and performance requirements and is substantially equivalent to a legally marketed predicate device (K202377). It's a bench testing/laboratory study based on adherence to quantitative standards rather than a clinical trial or AI/ML model validation study.

Ask a specific question about this device

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.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile the meets all requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.

The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319-10.

The provided text describes the acceptance criteria and performance of "Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs." This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to an existing predicate device (K141982).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared to relevant ASTM standards. The table below summarizes the acceptance criteria and the device's reported performance:

Note: The acceptance criteria for Carmustine (BCNU) and Thiotepa are highlighted with a warning due to their extremely low permeation times, which the device matches.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for permeation, physical properties, etc.). However, the tests were conducted according to established ASTM standards (D6319-10, D6978-05, D6124-06, D5151-06) and ISO 10993-10:2010(E). These standards typically specify the minimum sample sizes required for such testing.

The provenance of the data is from WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia (based on the submitter's address). The study is non-clinical performance data, indicating it's laboratory testing rather than data collected from patients. It is implicitly retrospective as it reports the results of tests already conducted.

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

This information is not applicable to this document. The "ground truth" here is based on objective, standardized laboratory measurements and performance against established ASTM and ISO standards, not on subjective expert consensus. No individual experts were used to establish ground truth in the way one would for diagnostic AI.

4. Adjudication Method for the Test Set

This is not applicable. The data presented are based on direct physical and chemical testing, adhering to specific methodologies outlined in the referenced standards. There is no ambiguous interpretation that would require an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

This is not applicable. This document concerns a physical medical device (examination gloves) and its material properties, not an AI or imaging diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. This document describes the performance of a physical product and does not involve any algorithms or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by objective measurements and adherence to recognized international standards. Specifically:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties, material).
• ASTM D6978-05: Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs (for chemotherapy drug permeation).
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves (for powder freedom).
• ISO 10993-10:2010(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
• ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves (for watertightness).

8. The Sample Size for the Training Set

This is not applicable. This document describes the testing of a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This is not applicable, as there is no training set for this type of device submission.

Ask a specific question about this device

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.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

• Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes

Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meets all the requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the qlove surface. The qlove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meets ASTM standard D6319-10.

The provided document describes the acceptance criteria and performance of the "Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs" to demonstrate substantial equivalence to a predicate device (Kimberly-Clark STERLING Nitrile Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim, K081089).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to various ASTM standards and performance comparable to the predicate device. The reported device performance indicates compliance with these standards.

Study Proving Device Meets Acceptance Criteria:

The studies cited are non-clinical performance tests conducted to demonstrate compliance with recognized industry standards. The submission explicitly states that "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements)." This implies specific tests were performed on the device to prove its compliance with each standard.

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

• The document does not specify the sample sizes used for the individual tests (e.g., how many gloves were tested for permeation, physical properties, or biocompatibility).
• The data provenance is non-clinical test data, performed by the manufacturer, WRP Asia Pacific Sdn Bhd, located in Malaysia. The tests are reported as being compliant with internationally recognized ASTM standards.

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

• This is not applicable to this type of submission. The "ground truth" for glove performance is established by adherence to standardized testing protocols (e.g., ASTM D6978-05 for chemotherapy drug permeation), not by expert consensus in a clinical setting.
• The document does not mention any medical experts' involvement in establishing test results or ground truth. The tests are laboratory-based.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are typically associated with human interpretation of results, often in clinical or image-based studies. Here, the results are quantitative measurements against predefined standard thresholds.

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 medical gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

• Not applicable. This involves physical product performance, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the device's performance is compliance with established, quantitative, and standardized test methods (e.g., ASTM D6319-10 for physical characteristics, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993-10 for biocompatibility, and ASTM D5151-06 for watertightness). The results are direct measurements against these standards.

8. The sample size for the training set

• Not applicable. This device is a physical product (gloves) and does not involve machine learning or AI, thus 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 this device.

Ask a specific question about this device

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.

The Dermagrip powder free blue nitrile patient examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the qloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

This document is a 510(k) summary for the Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile. It provides information about the device's characteristics and how it meets acceptance criteria, primarily through comparison to established standards and a predicate device.

Here's a breakdown of the requested information based on the provided text:

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

2. Sample sizes 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 used for each specific test (e.g., for biocompatibility, watertightness, etc.). It only indicates that the device's performance "Meets" the respective standards. The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective, beyond acknowledging that the manufacturer (WRP Asia Pacific Sdn Bhd) is located in Malaysia.

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 type of information is not applicable to the device described. The device is a patient examination glove, and its performance is assessed against established engineering and biocompatibility standards (ASTM, ISO), not through expert interpretation of medical images or clinical outcomes that require "ground truth" established by medical experts in a diagnostic context. The "ground truth" here is the pass/fail criteria defined by the standards.

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

Not applicable. As explained above, the assessment is against predefined technical and biological standards, not through adjudication of expert opinions on a 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

Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and effects on human readers are irrelevant.

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

Not applicable. This device is a physical product (a glove), not an algorithm or software.

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 industry standards and regulatory requirements. For example:

• Dimensions, Physical Properties, Thickness: Defined by ASTM D6319-10.
• Powder Free: Defined by ASTM D6124-06 (≤ 2 mg/glove).
• Biocompatibility: Defined by ISO 10993-10:2010(E) and Consumer Product Safety Commission regulations (absence of primary skin irritation, absence of dermal sensitization).
• Watertight: Defined by ASTM D5151-06 (passing the water leak test).
• Intended Use, Material, Color, Texture, Size, Single Use: Compliance with descriptive criteria or labeling guidance.

These standards provide objective, measurable criteria for the device's performance.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development and testing follow established engineering and manufacturing quality control processes.

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

Not applicable, as no training set is used for this type of device.

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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.

Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile

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 specific sample sizes for tests like biocompatibility or watertightness. The performance is reported against ASTM and ISO standards, which typically involve defined sample sizes. For example, ASTM D6319-10 and ASTM D5151-06 would specify the number of gloves to be tested for dimensions, physical properties, and watertightness. However, these specific numbers are not provided in this 510(k) summary.

The data provenance is not explicitly stated as country of origin, but the manufacturer is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing would presumably have been conducted in accordance with international standards (ASTM, ISO) adopted by the FDA. The text describes non-clinical performance data.

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

This information is not applicable and not provided. The ground truth for this device (examination gloves) is established through adherence to recognized international and national standards (ASTM, ISO, FDA regulations) that specify physical, chemical, and biological performance requirements. There are no "experts" establishing ground truth in the sense of medical diagnosis; it's about meeting engineering and material performance specifications.

4. Adjudication Method for the Test Set:

Not applicable. This device's performance is objectively measured against quantifiable standards, not through subjective human assessment requiring adjudication.

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 relevant for diagnostic or AI-assisted devices where human interpretation is involved. For examination gloves, the performance is assessed through material and physical property testing.

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

Not applicable. "Standalone performance" refers to the performance of an algorithm or AI system without human involvement. This device is a physical medical device (gloves), not a software or AI product.

7. The Type of Ground Truth Used:

The ground truth used is based on International and National Standards Specifications. These include:

• ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
• ISO 10993-10:2002(E) (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
• Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (related to primary skin irritation and dermal sensitization)
• Medical Glove Guidance Manual - Labeling
• FDA 21 CFR 880.6250 (Patient Examination Gloves regulations)

8. The Sample Size for the Training Set:

Not applicable. Examination gloves are physical devices, not machine learning models. Therefore, 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 this device.

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The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Carmustine (BiCNU). Thio-Tepa. Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide and Paclitaxel].

WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.

Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs meet all the requirements of ASTM standard D6978-05, D5712-05e1 and FDA 21 CFR 880.6250.

Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs," based on the provided 510(k) summary:

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 test (dimensions, physical properties, etc.). However, it refers to ASTM standards, which typically outline sampling plans.

• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is implied the testing was conducted by the manufacturer (WRP Asia Pacific Sdn Bhd in Malaysia) to meet international standards.

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

This information is not applicable to this type of device and study. The "ground truth" for the performance characteristics of examination gloves is established through objective physical and chemical testing against recognized industry standards (e.g., ASTM standards), not through expert consensus or interpretation of medical images/data.

4. Adjudication Method for the Test Set

This information is not applicable as there were no subjective assessments requiring adjudication. The tests conducted are objective measurements against predefined criteria.

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 performed for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This device is an examination glove, which does not involve human interpretation in the same manner.

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

Yes, a standalone performance evaluation was conducted. The device (the glove) itself was tested against the various ASTM standards and performance criteria. There is no "algorithm" or "human-in-the-loop" component in the functionality of an examination glove beyond its intended physical properties.

7. The Type of Ground Truth Used

The ground truth used for this device's testing is based on objective, standardized measurements and criteria defined by established industry standards (ASTM). For example:

• Physical measurements (dimensions, thickness)
• Chemical analysis (powder content)
• Biocompatibility assays (skin irritation, sensitization)
• Barrier integrity tests (watertightness, chemotherapy drug permeation)

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML-based system that requires a "training set" in the conventional sense. The manufacturing process and quality control would involve ongoing testing, but there isn't a "training set" like there would be for an algorithmic model.

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

This information is not applicable for the reasons stated in point 8.

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