Search Results

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 and Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. 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.

This document describes the premarket notification (510(k)) for the Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant. The focus of the study is on the non-clinical performance testing of the gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against several standards, including ASTM D6319, ASTM D6124, ASTM D412, ASTM D3767, ASTM D5151, and ASTM D6978, as well as ISO 10993 for biocompatibility.

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

The document primarily describes non-clinical testing.

• For the watertight test, the sample size used was 500 pieces.
• Specific sample sizes for other tests like physical properties, dimensions, residual powder, and biocompatibility are not explicitly stated in quantity, but imply a representative sample was tested to meet the ASTM and ISO standards.
• The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, WRP Asia Pacific Sdn Bhd, based in Malaysia. The studies are prospective as they are testing the new device.

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

This information is not applicable as the document describes non-clinical performance testing of medical gloves against established engineering and biological standards, not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is defined by the specific test methods and their measurable endpoints (e.g., breakthrough time, tensile strength values).

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical performance testing against objective standards, not subjective assessments requiring adjudication by multiple readers.

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

This information is not applicable. The device is a medical glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.

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

This information is not applicable. The device is a medical glove, and no algorithm or AI component is involved.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on established industry standards and regulatory requirements, including:

• ASTM standards (e.g., ASTM D412, D3767, D5151, D6124, D6978) for physical properties, dimensions, watertight integrity, residual powder, and chemical permeation.
• ISO 10993 standards for biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity, acute systemic toxicity).
  These standards define objective, measurable criteria for the glove's performance.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. Performance is evaluated against pre-defined, physical, and chemical standards.

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

This information is not applicable due to the absence of a training set for this device. The "ground truth" for evaluating the glove's performance is established by the methodologies and specified outcomes mandated by the referenced ASTM and ISO standards.

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:

*WARNING: Do not use Carmustine and ThioTepa.

Not Found

This document is a 510(k) premarket notification for a medical device, specifically Powder Free Nitrile Surgical Glove, Sterile, Tested For Use With Chemotherapy Drugs. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested details about acceptance criteria, test sets, experts, and ground truth are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a surgical glove.

However, based on the provided text, we can extract information regarding the device's performance against specific standards:

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

The acceptance criteria here are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is presented in the table provided in the "Indications for Use" section. For most drugs, the performance exceeds 240 minutes, with the notable exception of Carmustine and ThioTepa.

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

The document does not specify the sample size for the testing of the chemotherapy drug permeation. It is a standard test defined by ASTM D6978, which would outline the appropriate sample size. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. This testing is typically prospective, performed on newly manufactured batches of gloves.

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 question is not applicable. The "ground truth" here is the measured breakthrough time of chemotherapy drugs through the glove material, determined by laboratory testing according to ASTM D6978. It does not involve expert medical opinion or consensus.

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

This question is not applicable. Adjudication methods are typically used when human judgment is involved in establishing a ground truth, such as in clinical studies with expert readers. Here, the "truth" is an objective measurement from a standardized test.

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 question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve an algorithm.

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

The ground truth used is objective measurement based on a standardized laboratory test (ASTM D6978). The breakthrough detection time is a direct measurement of how long it takes for a chemotherapy drug to permeate through the glove material.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of testing the performance of a physical device like a surgical glove against a standardized permeation test.

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

This question is not applicable, as there is no training set mentioned in this context.

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.

Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) 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.

This document is a 510(k) premarket notification for a medical device: "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)" manufactured by WRP Asia Pacific Sdn Bhd.

Based on the provided information, the acceptance criteria and the study that proves the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D412-16) would specify the required sample size.
• Dimension: Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D3767 - 03(2014)) would specify the required sample size.
• Watertight:
  • Sample Size: 315 pieces
  • Data Provenance: The data is from non-clinical testing performed on the device itself. The country of origin of the data is not specified, but the manufacturer is WRP Asia Pacific Sdn Bhd in Malaysia. This is prospective testing on the manufactured device.
• Residual Powder:
  • Sample Size: 5 pieces
  • Data Provenance: Non-clinical testing on the device. Country of origin not specified, manufacturer is Malaysian. This is prospective testing.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): These tests were performed, and results indicated "Passes" or "Not a primary skin irritant/contact sensitizer" or "Exhibit severe cytotoxicity reactivity at 100%, 66%, and 44% extract concentration. Moderate cytotoxicity reactivity at 30%, mild cytotoxicity reactivity at 20% and slight cytotoxicity reactivity at 15% extract concentrations." and "It is concluded that the extracts (polar and non-polar) of the product did not show any systemic toxicity." The exact number of samples (and animals for in-vivo tests) used for these biocompatibility tests is not detailed in the provided summary, but the standards (ISO 10993 series and Consumer Product Safety Commission regulations) would dictate the sample sizes. Data provenance is non-clinical testing on the device.

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

This document describes non-clinical performance testing of a physical medical device (gloves). The "ground truth" for these tests is established by published, internationally recognized standards (ASTM, ISO, FDA 21 CFR, CPSC regulations) and the objective measurements derived from these tests. These studies do not involve human experts establishing a subjective ground truth, as would be the case for AI/diagnostic imaging devices. Therefore, this information is not applicable.

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

Not applicable. This is not a study involving subjective human interpretation that would require an adjudication method. The testing involves objective physical and chemical measurements against pre-defined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a 510(k) submission for a physical medical device (examination gloves), not an AI/Software as a Medical Device (SaMD) that would typically involve 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 for a physical medical device.

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

The "ground truth" for the performance characteristics of these gloves is defined by:

• Standardized Test Methods: ASTM D412-16, ASTM D3767 - 03(2014), ASTM D5151-06, ASTM D6124-06.
• Regulatory Standards: FDA 21 CFR 880.6250.
• Biocompatibility Standards: ISO 10993-10:2002(E), ISO 10993-5:2009 (E), ISO 10993-11:2017 (E), and Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.

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

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable. No training set is involved.

Ask a specific question about this device

A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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.
Carmustine (BCNU) 3.3mg/ml 30.4
Cisplatin 1.0mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Dacarbazine 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Thiotepa 10.0mg/ml 59.0
Vincristine Sulfate 1.0mg/ml > 240

CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.

Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.

The powder free nitrile surgical glove 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 with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.

This document describes the acceptance criteria and performance study for the Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823).

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against ASTM standards for various characteristics and against the ASTM D6978-05 standard for chemotherapy drug permeation.

Note regarding Chemotherapy Drug Permeation: For Carmustine and Thiotepa, a "CAUTION" statement is included, indicating average breakthrough times of 30.4 minutes and 59.0 minutes, respectively. This implies that while the glove offers some protection, it is not indefinitely resistant to these specific drugs, and users should be aware of these breakthrough times. The other listed drugs showed breakthrough times greater than 240 minutes, indicating high resistance under the tested conditions.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for watertightness, number of samples for chemotherapy permeation). However, it indicates adherence to relevant ASTM standards (D3577-09, D6978-05, D5151-06, D6124-06) and ISO standards (ISO 10993-10), which would dictate appropriate sample sizes for these types of tests.

The data provenance is not explicitly stated in terms of country of origin for the testing, but the submitter is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing adheres to international and US standards (ASTM, ISO, 21 CFR), suggesting a globally recognized testing methodology. The studies are non-clinical performance tests.

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

This information is not applicable as the ground truth for medical gloves is established through objective physical, chemical, and biological testing against established international and national standards (ASTM, ISO, FDA regulations). There is no mention of human expert assessment or consensus being used to establish a "ground truth" for the device's performance characteristics in the way it might be for diagnostic AI.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements and compliance with predefined standards, not on human interpretation or adjudication of subjective data.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes the testing of a medical device (surgical glove) based on its physical properties and resistance to chemicals, which does not involve human readers interpreting data alongside an AI.

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 product (surgical glove), not an AI algorithm. Its performance is measured directly through laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Performance against established standards: This includes physical property measurements (tensile strength, elongation, dimensions), impermeability (watertightness), chemical resistance (chemotherapy drug permeation), cleanliness (powder-free), and biocompatibility (skin irritation, sensitization) as defined by ASTM and ISO standards and FDA regulations.
• The metrics are objective and quantitatively measured (e.g., length in mm, breakthrough time in minutes, mg/glove for powder, MPa for tensile strength).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is likely subject to quality control and statistical process control, which involves ongoing testing and process adjustments, but this is distinct from an AI training set.

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

This is not applicable for the reason stated in point 8.

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