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A Nittile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs.

Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

This document is a 510(k) premarket notification for a medical device: "Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs".

The main acceptance criteria for this device, beyond its primary function as an examination glove, is its resistance to permeation by various chemotherapy drugs. This is evaluated by the "Minimum Breakthrough Detection Time (minutes)" for each tested drug.

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

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

Note: The document itself specifies a warning based on these results: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (15.0 minutes and 30.1 minutes respectively). While the provided table states the reported performance, the implied acceptance criteria for safe use would be a breakthrough time considered acceptable for handling (likely much higher than 15 or 30 minutes, commonly 240 minutes per ASTM D6978). The device meets the criteria by reporting its performance, allowing users to make informed decisions and the FDA to determine substantial equivalence.

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 for the test set (number of gloves tested or repetitions per drug). It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. We only know the applicant is YTY Industry (Manjung) Sdn Bhd from 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 device is a physical product (nitrile examination glove) and not an AI or diagnostic tool requiring expert interpretation of images or data. Therefore, the concept of "experts establishing ground truth" in the typical sense for test sets of AI models is not applicable here. The ground truth (breakthrough time) is established through standardized laboratory testing protocols (likely ASTM D6978 for chemotherapy drug permeation), not human expert consensus.

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

Not applicable for a physical product performance test. This concept is relevant for studies involving human interpretation or subjective assessment where consensus among multiple reviewers is needed to establish 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

Not applicable. This device is a physical product (glove), not an AI or assistive diagnostic technology.

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 software.

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

The ground truth for the chemotherapy drug permeation is established through laboratory testing using standardized methods, likely following a standard like ASTM D6978 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs". This involves precise measurement of the time it takes for a detectable amount of a chemotherapy drug to pass through the glove material.

8. The sample size for the training set

Not applicable. This device is a physical product. The concept of a "training set" is relevant for machine learning models, not for traditional manufacturing and testing of physical goods.

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

Not applicable, as there is no "training set" in the context of this device.

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

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

Aloe Vera: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, and Vincristine Sulfate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.

Non-Sterile, Powder Free Nitrile Examination Gloves: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, Vincristine Sulfate, and Fentanyl Citrate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.

Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate.

The provided text is related to a 510(k) premarket notification for nitrile examination gloves and does not contain information about the acceptance criteria or a study that typically involves AI/ML device performance. Instead, it details the indications for use and the gloves' resistance to permeation by chemotherapy drugs and fentanyl citrate, in accordance with ASTM D6978.

Therefore, I cannot extract the information required to answer your questions as they pertain to AI/ML device performance studies and acceptance criteria. The document focuses on regulatory clearance for medical gloves based on chemical resistance testing, not on an AI/ML algorithm's performance.

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

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes

WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA

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

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate:

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes

CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS

Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue; Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

This document describes two types of non-sterile, powder-free nitrile examination gloves:

1. Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
2. Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

The acceptance criteria for both devices are primarily based on their resistance to permeation by chemotherapy drugs, as tested according to ASTM D6978 Standard Practice. For the second device, resistance to Fentanyl Citrate is also included.

The study proving the device meets the acceptance criteria is detailed in the "Indications for Use" sections for each glove type.

1. Table of Acceptance Criteria and Reported Device Performance

Device 1: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue

Note: The document explicitly warns: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (11.3 minutes and 7.4 minutes, respectively). This implicitly sets an acceptance criterion that usage with these drugs is not recommended, rather than a performance threshold for them. For other drugs, a permeation time of "> 240 minutes" appears to be the target performance for safe use.

Device 2: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

Note: The document states: "CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS". Similar to Device 1, this indicates that while tested, their permeation times (30.3 minutes and 91.0 minutes, respectively) are lower than the target for other drugs, suggesting a cautionary use or implicit lower acceptance for these specific substances.

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

The document specifies that the gloves were "tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

• Sample Size for the Test Set: The document does not explicitly state the sample size (e.g., number of gloves or tests performed per drug) used for these tests. The ASTM D6978 standard would likely specify the required number of replicates.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted by YTY Industry (Manjung) Sdn Bhd, located in Malaysia, suggesting the tests were performed in Malaysia. The nature of laboratory testing like this is inherently prospective for the specific batch or design of gloves being evaluated.

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 in the context of this document. The "ground truth" here is the physical measurement of chemical permeation, determined by laboratory testing methods described in ASTM D6978, rather than expert interpretation of medical images or diagnostic data. There is no indication of experts being used to establish a ground truth for the test results.

4. Adjudication method for the test set

This question is not applicable. The test results are objective chemical permeation measurements (breakthrough detection time), not subjective interpretations that require adjudication by experts.

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. The device is a medical glove, not an AI-powered diagnostic tool requiring human interpretation or MRMC studies.

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

This question is not applicable. The device is a medical glove, not an algorithm. The performance described is that of the physical product itself.

7. The type of ground truth used

The ground truth used is laboratory measurement of chemical permeation according to the ASTM D6978 standard. This standard describes methods to evaluate the resistance of medical gloves to permeation by chemotherapy drugs, typically by detecting the breakthrough of a specific chemical through the glove material over time.

8. The sample size for the training set

This question is not applicable. The device consists of physical gloves, not a machine learning model, and therefore does not have a "training set" in the computational sense. The manufacturing process of gloves might involve quality control and material testing, but this is distinct from training a dataset for an algorithm.

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

This question is not applicable, as there is no "training set" for this physical device.

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

Non-Sterile, PF Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs - Blue

The provided document is a 510(k) clearance letter from the FDA for "Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs - Blue." This document does not describe an AI/ML powered device, but rather a standard medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for an AI device is not applicable to this document.

The document does include a table indicating the performance of the gloves with various chemotherapy drugs, specifically the "Average Breakthrough Detection Time." This table could be interpreted as describing device performance against acceptance criteria for chemotherapy drug permeation, but it is not related to AI/ML performance.

Acceptance Criteria and Reported Device Performance (as related to chemotherapy drug permeation for the gloves):

The document states that "Carmustine (3.3 mg/ml): 11.3 minutes" and "ThioTEPA (10.0 mg/ml): 7.4 minutes" have "extremely low permeation time," which implies that for these drugs, the gloves do not offer extended protection. This information would be crucial for users to understand the limitations of the device.

All other requested information about an AI/ML study is not present in this document as it is not a submission for an AI/ML medical device.

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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 Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - 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.

The provided text describes the acceptance criteria and performance data for two types of nitrile examination gloves: "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)" and "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)". The information is presented as a 510(k) summary, comparing the subject devices to a predicate device (K161215).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the gloves are primarily based on ASTM standards (ASTM D6319-10 for physical and dimensional properties, ASTM D6124-06 for powder-free claims, and ASTM D6978-05 for chemotherapy drug permeation), as well as ISO 10993-10 for biocompatibility. The reported device performance is compared against these standards and the predicate device.

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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:

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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.

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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.

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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.

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