Search Results

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

This document is a 510(k) Pre-market Notification for medical gloves, focusing on their resistance to chemotherapy drugs. It details the performance of "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue)" against a range of chemotherapy agents.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for chemotherapy drug permeation are defined by the "Average Breakthrough Detection Time" for each drug. While the specific numerical acceptance criteria (e.g., minimum time) are not explicitly stated as distinct "criteria" separate from the results, the implication is that the longer the breakthrough time, the better the performance. For many drugs, a breakthrough time of "> 240 minutes" is presented, suggesting this is a desirable outcome or a de facto acceptance benchmark for long-term protection. The device performance is the directly measured average breakthrough detection time for each drug.

Below are the tables summarizing the performance for both "Original Blue" and "Cobalt Blue" glove variations, as tested against various chemotherapy drugs.

Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Original Blue

Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Cobalt Blue

In addition to chemotherapy drug permeation, the gloves were also tested against other specifications, including:

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

The document does not explicitly state the specific sample sizes used for testing each individual chemotherapy drug permeation or other properties. However, it does state that the device "meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250." These ASTM standards would typically define the appropriate sample sizes and testing methodologies.

The data provenance is not specified, but the submission is from "YTY Industry (Manjung) Sdn. Bhd., Malaysia," suggesting the tests were likely conducted on products manufactured or supervised by this Malaysian entity. The tests appear to be a prospective evaluation of the device's performance against established standards.

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

This document describes performance testing of physical properties and chemical permeation resistance of gloves, not diagnostic or clinical interpretation. Therefore, the concept of "experts used to establish ground truth" as it would apply to image analysis or clinical diagnosis is not applicable here. The "ground truth" is established by adherence to recognized industrial standards (ASTM D6319-10 and D6978-05) and FDA regulations. These standards define the scientific methods and procedures for evaluating glove performance.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require 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 evaluating the impact of a device (often AI-based) on human reader performance in tasks like diagnostic interpretation. This document pertains to the physical and chemical performance of medical gloves, not assistive diagnostic technology.

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

Yes, a standalone performance assessment was done. The entire study described is a standalone evaluation of the glove's performance against various physical and chemical challenges, without human-in-the-loop interaction in the context of diagnostic interpretation. The breakthrough detection times and physical properties are direct measurements of the device's inherent characteristics.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and scientific testing procedures. Specifically:

• ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: This standard outlines the methodology for determining the breakthrough detection time of chemotherapy drugs through glove material.
• ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application: This standard sets specifications for physical properties like dimensions, physical performance, and powder content.
• ISO 10993-10 (2010) and Consumer Product Safety Commission II, Part 1500: These standards govern biocompatibility testing (primary skin irritation and dermal sensitization).
• ASTM D5151-06: This standard relates to water tightness testing.

The results obtained through these standardized testing methods serve as the "ground truth" for the device's performance.

8. The Sample Size for the Training Set

Not applicable. This device is a medical glove, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of an algorithm.

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

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

Ask a specific question about this device

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

Non-Sterile, Powder Free Nitrile Examination Gloves – Orange, Green, Blue and Violet Color Color meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and performance data for "Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color," which is seeking substantial equivalence to a predicate device (K052502).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document explicitly states that the device "meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application." The tables provided, particularly on pages 5 and 7, show the performance of the "Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color" against these ASTM D6319-10 standards, and also against the FDA 1000ml Water Leak Test and ISO 10993-10 (2010) for biocompatibility.

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

• Sample Size for Test Set: The specific sample sizes for each test (e.g., how many gloves were tested for length, how many for freedom from holes) are not explicitly detailed. For the "Watertight (1000ml)" test, it mentions "Multiple Normal GII AQL = 2.5", and the acceptance criterion is "(Accept 1, Reject 7)", which implies a sampling plan based on AQL principles, but not a fixed number of samples. This is a common statistical sampling approach in quality control of manufactured goods.
• Data Provenance: The manufacturer is YTY Industry (Manjung) Sdn. Bhd., located in Sitiawan, Perak, Malaysia. Therefore, the data provenance is Malaysia. The study is a prospective test of the manufactured gloves against established standards, not a retrospective analysis.

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

• This information is not provided as it's not relevant for this type of device (nitrile examination gloves). The "ground truth" for glove performance is established by objective, standardized tests (ASTM, ISO, FDA methods), not by expert interpretation.

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

• None. As mentioned above, the performance of examination gloves is determined by objective physical and chemical testing against established standards, not by human adjudication of "ground truth".

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:

• A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert human readers interpret images or data, often with or without AI assistance. This device (examination gloves) does not involve human interpretation or AI assistance in its intended use or performance evaluation.

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

• A standalone algorithm performance study was not done. This device is a physical medical product, not an algorithm or AI system.

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

• The "ground truth" for the performance of these gloves is defined by established international and national standards and test methods:
  • ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
  • FDA 1000ml Water Leak Test
  • ISO 10993-10 (2010) (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
  • ASTM D6124-10 (Reapproved 2011) (Residual Powder on Medical Gloves)
  • ASTM D5151-06 (Reapproved 2011) (Detection of Holes in Medical Gloves)

8. The sample size for the training set:

• This information is not applicable. This is a physical manufactured product, not an AI/ML algorithm that requires a "training set". The manufacturing process is subject to quality control and adherence to standards.

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

• Not applicable. As above, there is no "training set" for this type of medical device.

Ask a specific question about this device

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

Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, and Vanilla meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

Here's a summary of the acceptance criteria and study information for the "Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla" based on the provided document:

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 exact sample size used for each specific test (e.g., number of gloves tested for watertightness, physical properties, etc.). It refers to meeting general ASTM standards which typically define sample sizes for such tests.
• The data provenance is Malaysia, as the manufacturing company (YTY Industry (Manjung) SDN. BHD.) is based there.
• The study appears to be prospective as it's a submission for product clearance, implying these tests were conducted on the device being submitted.

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

• This is not applicable as the ground truth is established through adherence to standardized international and FDA-recognized test methods and specifications (ASTM D6319-10, ISO 10993-10, ASTM D5151-06, ASTM D6124-10). These standards define objective, measurable criteria, and therefore do not require expert consensus for interpretation in the same way, for example, diagnostic image analysis might.

4. Adjudication Method for the Test Set:

• None in the typical sense of expert adjudication. The tests (e.g., water leak, tensile strength, irritation) produce objective, quantitative results that are compared directly against the predefined acceptance criteria from the relevant ASTM and ISO standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is a key component, and the AI's effect on human performance is being evaluated. This submission is for examination gloves, which do not involve human interpretation of AI output.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The performance evaluation is based on the physical and chemical properties of the gloves themselves.

7. Type of Ground Truth Used:

• The ground truth is based on objective, measurable criteria defined by established international and national standards for medical gloves. Specifically:
  • ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
  • ASTM D5151-06 (2011): Standard Test Method for Detection of Holes in Medical Gloves.
  • ASTM D6124-10 (2011): Standard Test Method for Residual Powder on Medical Gloves.
  • ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization (for biocompatibility).

8. Sample Size for the Training Set:

• Not applicable. This is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of gloves is subject to Quality Management Systems (e.g., 21 CFR Part 820) which involve process control and quality assurance, not machine learning training.

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

• Not applicable, for the same reasons as point 8.

Ask a specific question about this device

The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided document describes the performance data for various models of Non-Sterile, Powder Free Nitrile Examination Gloves from YTY Industry (MANJUNG) SDN. BHD. based on ASTM and FDA standards. This is not an AI/ML device, therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 are not applicable.

Here's the summary of the acceptance criteria and reported device performance:

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

Study Proving Device Meets Acceptance Criteria:

The study summarized in the document is a series of non-clinical tests performed on the Non-Sterile, Powder Free Nitrile Examination Gloves (across various models and colors).

• Standards Used: The performance of the devices was evaluated against the following standards:

  • ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application.
  • FDA 1000ml Water Leak Test (ASTM D5151-06 (2011) for watertightness with AQL GII 2.5).
  • ISO 10993-10 for Primary Skin Irritation and Dermal Sensitization (Biocompatibility).
  • ASTM-D6124-10 (Reapproved 2011) for Residual Powder.

• Test Results: The table above details the specific performance results for each characteristic, demonstrating that all tested models of the gloves met or exceeded the specified acceptance criteria for dimensions, physical properties (tensile strength, ultimate elongation, before and after aging), freedom from holes, powder-free status (moisture content, residual powder), and biocompatibility.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states for "Freedom from holes" that the sample size for the water leak test was 80 gloves per lot, with a lot size of 16,000 gloves. The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, the manufacturer is stated as YTY INDUSTRY (MANJUNG) SDN. BHD. from Malaysia. The tests are non-clinical, implying they were likely conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is not an AI/ML device. The ground truth is established by standardized testing protocols (ASTM, ISO, FDA tests), not by expert consensus in the human interpretation sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is not an AI/ML device. The "ground truth" is determined by objective measurements and standardized testing procedures.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is not an AI/ML device and human "readers" or interpretations are not part of its function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is defined by objective measurements and adherence to international and national standards (ASTM, ISO, FDA specifications) for physical properties, barrier integrity, and biocompatibility. This includes measurements of length, width, thickness, tensile strength, elongation, freedom from holes (water leak test), moisture content, residual powder, and biological response (skin irritation and sensitization).

8. The sample size for the training set
This information is not applicable as the device is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.

9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML device.

Ask a specific question about 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 fingers to prevent contamination between patient an examiner.

Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs, meets all the current specifications listed under ASTM Specifications D6319-05 , Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05, Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs.

The provided document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs" by YTY INDUSTRY (MANJUNG) SDN. BHD. This is a 510(k) premarket notification summary, demonstrating substantial equivalence to a predicate device (K101822).

The study primarily focuses on demonstrating that the gloves meet established industry standards and FDA requirements for patient examination gloves and resistance to chemotherapy drugs.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on ASTM D6319-10 (for examination gloves) and ASTM D6978-05 (for chemotherapy drug permeation), along with FDA 1000ml watertight test and powder content requirements. The reported device performance is for two colors: "Original Blue" and "Cobalt Blue."

Chemotherapy Breakthrough Detection Time (in minutes):

Note: Carmustine and Thiotepa show very low breakthrough times, and a warning is included in the labeling that these chemicals are not recommended for use with these gloves.

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 for watertight test, number of gloves for physical properties, amount of chemotherapy testing). However, it implies testing according to ASTM standards, which would define appropriate sample sizes.

The data provenance is not explicitly stated as "retrospective" or "prospective" but represents testing conducted by the manufacturer (YTY INDUSTRY (MANJUNG) SDN. BHD.) for the purpose of this 510(k) submission. The company is located in Malaysia, suggesting the data originates from testing facilities associated with the manufacturer or their designated testing laboratories. Chemotherapy testing was performed by "ARDL CHEMICAL ANALYTICAL SERVICES."

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

This type of submission (for examination gloves) does not typically involve human experts establishing ground truth in the way it would for AI-driven diagnostic devices. The acceptance criteria are based on established industrial standards (ASTM) and regulatory requirements (FDA). The "ground truth" here is the pass/fail criteria defined by these standards for physical properties, barrier integrity, and chemical resistance. Expert involvement would be in interpreting these standards and overseeing the testing, rather than reaching a consensus on individual test outcomes.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is determined by adherence to established, objective test methods and performance specifications from ASTM standards and FDA requirements. There isn't a subjective assessment that requires adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical product (examination gloves), not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Industry Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ASTM D6978-05 (Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs).
• Regulatory Requirements: FDA 1000ml watertight test criteria and specific powder content limits.
• Biocompatibility Testing: Standards for primary skin irritation and sensitization tests.

These standards provide objective, measurable criteria for the performance of the gloves.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. The physical properties and chemical resistance are inherent to the product's design and manufacturing process, and performance is evaluated against defined standards, not through machine learning.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the accepted and universally applied methods and specifications outlined in the ASTM standards and FDA guidelines.

Ask a specific question about this device

Ask a specific question about this device

This Non-Sterile, Powder-Free, Black Nitrile 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.

Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination Gloves for Medical Application.

The acceptance criteria and device performance for the Non-Sterile, Powder-Free, Black Nitrile Examination Gloves are detailed below, based on the provided document K061553.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the exact sample size used for each individual test (e.g., number of gloves tested for watertightness, length, etc.). However, for the watertight test, it references "Multiple Normal GII" with an AQL (Acceptable Quality Level) of 2.5, which implies a statistically determined sample size based on lot size, as per ASTM standards for inspection.
• Data Provenance: The document does not specify the country of origin of the data. It is presented as summary performance data based on ASTM D6319-00a and FDA 1000ML watertight tests conducted by the manufacturer, YTY Industry (Manjung) Sdn Bhd, located in Malaysia. The nature of these tests (dimensional, physical property, chemical testing) suggests they are laboratory-based tests rather than human subject data, thus the terms "retrospective or prospective" are not directly applicable in the biological or clinical sense but rather describe the execution of a standardized test.

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

This device is a medical glove, and the "ground truth" for its performance is established through adherence to standardized physical and chemical specifications, not through expert clinical interpretation. The performance data is objective and measurable against the ASTM D6319-00a standard. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense is not applicable here.

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

Not applicable. The "tests" are objective measurements against a standard, not interpretations requiring adjudication.

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

Not applicable. This device is a medical glove, not an AI-assisted diagnostic tool.

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

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

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

The "ground truth" for the device's performance is the objective measurements and specifications defined by the ASTM D6319-00a standard for nitrile examination gloves. These include physical properties (length, width, thickness, tensile strength, elongation) and chemical properties (powder content), as well as a watertightness test.

8. The sample size for the training set:

Not applicable. This device is a physical product, a medical glove, and does not involve AI or machine learning models that require a training set.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

The Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves 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.

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 and FDA Water leak test.

Here's a breakdown of the acceptance criteria and the study details for the "NON-STERILE, ON-LINE POWDER-FREE, NITRILE BLUE & WHITE COLOR, EXAMINATION GLOVES," based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated for each test. The document refers to "Multiple Normal GI" for the watertight test, suggesting a sampling plan. However, the specific number of gloves tested for each individual parameter (length, width, thickness, tensile strength, etc.) is not provided.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission by YTY Industry (Manjung) Sdn Bhd (Malaysia) to the FDA (USA). The testing itself would likely have been conducted at a laboratory associated with the manufacturer or a third-party testing facility. The nature of the study is retrospective in the sense that results are presented as already obtained data to demonstrate compliance with existing standards.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This study primarily involves performance testing against engineering and material standards, not expert medical interpretation of images or patient conditions.
• Qualifications of Experts: Not applicable.

4. Adjudication Method

• Adjudication Method: Not applicable. This study relies on objective physical and chemical measurements rather than subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers interpret medical images. This document describes the performance of a medical device (examination gloves) based on established physical and chemical standards.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against predefined technical standards (ASTM D6319-00a83 and FDA requirements) without human intervention in the primary measurement process itself. The "algorithm" in this context is the glove itself, and its performance is measured directly.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this study is based on established industry standards and regulatory requirements.
  • ASTM D6319-00a83 Standard: This is a recognized material specification standard for patient examination gloves.
  • FDA 1000ML Watertight Test: A regulatory requirement specifically for medical gloves.
  • FDA Requirements for Powder Content: A specific regulatory limit for powder residue.
  • Biocompatibility Standards: Implicitly, the primary dermal irritation and sensitization tests are performed against predefined criteria for what constitutes a "pass."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device study. This is not an AI/machine learning model that requires training data. The gloves are manufactured and then tested for compliance with specifications.

9. How Ground Truth for the Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

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

Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a563 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are blue in colour and are powder free.

The provided document describes the acceptance criteria and performance of Non-Sterile Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves. This device is a medical glove, not an AI/ML powered medical device, and therefore the acceptance criteria and study detailed below are for the physical and chemical properties of the gloves, not an algorithm's performance.

Here's the information based on the provided text, formatted to your request where applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

In addition, the device successfully passed the Bio-compatibility Test, which included a Primary Dermal Irritation Test and a Guinea Pig Sensitization (Buehler) test.

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

The document does not explicitly state the sample size used for the test set for each of the physical property tests. The data provenance is also not specified beyond the fact that the manufacturer is YTY Industry (Manjung) Sdn Bhd (Malaysia). There is no indication whether the testing was retrospective or prospective.

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

This question is not applicable as the "ground truth" here refers to objective physical and chemical properties measured according to established ASTM standards, not subjective interpretations by human experts.

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

This question is not applicable as the testing involves objective measurements against predefined standards (ASTM D6319-00a3 and FDA watertight test for physical properties, and bio-compatibility tests) and does not involve human adjudication for "ground truth".

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 as the device is a medical glove, not an AI/ML powered medical device.

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

This question is not applicable as the device is a medical glove, not an AI/ML powered medical device.

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

The "ground truth" in this context is based on established industry standards and objective measurements. Specifically:

• ASTM D6319-00a3 Standard Specification for Nitrile Examination Gloves for Medical Application for physical properties (e.g., length, width, thickness, tensile strength, elongation).
• FDA 1000ML watertight test for barrier integrity.
• Bio-compatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) for biological safety.

8. The sample size for the training set

This question is not applicable as the device is a medical glove, not an AI/ML powered medical device that requires a training set.

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

This question is not applicable as the device is a medical glove, not an AI/ML powered medical device that requires a training set.

Ask a specific question about this device