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Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The difference between the devices is the color of powder free green nitrile examination gloves is green, the color of powder free pink nitrile examination gloves is pink, the color of powder free purple nitrile examination gloves is purple. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The medical device in question is the "Powder Free Green/Pink/Purple Nitrile Examination Gloves." The documentation provided describes the acceptance criteria and the non-clinical studies performed to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

• Length (mm): XS/S/M/L/XL: ≥230
• Width(mm): XS: 70±10mm; S: 85±10mm; M: 95±10mm; L: 110±10 mm; XL: 120±10 mm
• Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Physical Dimensions:
• Length(mm): XS/S/M/L/XL: 236~239 (Pass)
• Width(mm): XS 70; S 8586; M 9596; L 110~112; XL 120 (Pass)
• Finger: 0.23~0.47 (Pass)
• Palm: 0.26~0.46 (Pass) |
  | ASTM D5151-19 | Watertightness Test for Detection of Holes:
• Be free from holes when tested in accordance with ASTM D5151 | Pass |
  | ASTM D412 | Physical Properties:
• Before Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500% min
• After Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400% min | Physical Properties:
• Before Aging: Tensile Strength: 20.1628.78MPa (Pass); Ultimate Elongation: 522558% (Pass)
• After Aging: Tensile Strength: 18.2520.39MPa (Pass); Ultimate Elongation: 525555% (Pass) |
  | ASTM D6124 | Powder Content:
• Meet the requirements of Less than 2mg per glove | ≤0.46mg (Pass) |
  | ISO 10993-10 | Irritation:
• Non-irritating | Under the conditions of the study, not an irritant. |
  | ISO 10993-11 | Acute systemic toxicity:
• Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. |
  | ISO 10993-23 | Sensitization:
• Non-sensitizing | Under the conditions of the study, not a sensitizer. |

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

The document does not explicitly state the sample sizes for each specific test within the non-clinical studies. However, the tests were conducted according to recognized international and national standards (ASTM and ISO). The provenance of the data is not specified beyond indicating that the studies were performed as part of the regulatory submission process for the manufacturer, Hebei Titans Hongsen Medical Technology Co., Ltd. in China. These studies are typically prospective tests conducted on representative samples of the manufactured devices.

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

Not applicable. The ground truth for these types of devices (examination gloves) is established by performance against pre-defined, objective physical, chemical, and biological criteria outlined in the referenced standards (ASTM, ISO). Expert consensus is not typically used to establish ground truth for these quantitative, standardized tests.

4. Adjudication Method for the Test Set:

Not applicable. As the tests are based on objective, standardized measurements against specified criteria, an adjudication method for test results is not typically required. The results are quantitative and compared directly to the predetermined acceptance limits.

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

No. This type of study is not applicable for examination gloves, which are physical barriers designed for medical purposes. MRMC studies are typically used for diagnostic devices that involve human interpretation or decision-making aided by AI.

6. Standalone Performance Study:

Yes, a standalone study was performed. The non-clinical tests described (physical dimensions, watertightness, physical properties, powder content, biocompatibility) assess the performance of the device itself (the gloves) against established standards. This represents the standalone performance of the algorithm (in this context, the gloves as a product) without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

The ground truth used for the non-clinical tests is based on pre-established, objective criteria and limits defined within recognized international and national standards (e.g., ASTM D6319-19, ASTM D5151-19, ISO 10993 series). These standards outline the acceptable ranges for physical properties and the expected biological responses.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical product (gloves) whose performance is evaluated through non-clinical testing against established standards.

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

Not applicable, as there is no training set for a physical device like examination gloves.

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Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.

The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves. This type of medical device falls under Class I, reserved, and is a non-AI/ML device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML device performance (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) are not applicable in this context.

The document focuses on demonstrating substantial equivalence to a predicate device (K222498) through a series of bench tests and biocompatibility tests, primarily based on established ASTM and ISO standards for medical gloves.

Here's how the information provided relates to the closest equivalent of "acceptance criteria" and "proof" for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are the performance requirements set forth by relevant industry standards (ASTM, ISO). The "reported device performance" is the result of the bench tests demonstrating compliance with these standards.

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

• Sample Size: Not explicitly stated as a single number (e.g., N=X gloves). The testing is generally done on samples taken from production lots to ensure consistency. The specific sample sizes for each test are typically defined within the respective ASTM/ISO standards (e.g., AQL for freedom from holes).
• Data Provenance: The device manufacturer is Hebei Titans Hongsen Medical Technology Co., Ltd. in China. The tests were performed to demonstrate compliance with international standards (ASTM, ISO). The data is generated through prospective bench testing and biological evaluation in a controlled laboratory environment.

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

• Not Applicable: For this Class I device, the "ground truth" is defined by the objective, quantifiable parameters and pass/fail criteria established in the ASTM and ISO standards for glove performance and biocompatibility. There is no need for human expert consensus on subjective interpretations, as would be the case for image-based diagnostic AI. The tests are conducted by trained technicians in accredited labs according to standardized protocols.

4. Adjudication Method for the Test Set

• Not Applicable: As the "ground truth" is based on objective measurements and predefined standard thresholds, there is no need for an adjudication method by multiple human readers. Test results are either within the acceptable range or not.

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

• No: MRMC studies are relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This is a non-AI/ML medical glove, so such a study is not applicable.

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

• Yes (in concept, but not an "algorithm"): The "standalone performance" for this device refers to its ability to meet the physical and biological requirements of the standards independently, without human interaction during "use" in a diagnostic or interpretive sense. The bench tests and biocompatibility tests effectively demonstrate this "standalone" performance against defined metrics.

7. The Type of Ground Truth Used

• Standard-based Physical and Chemical Properties / Biological Reactions: The ground truth is established by the specified acceptance criteria within the referenced ASTM (e.g., D6319-19 for physical properties, D5151-06 for holes, D6124-06 for residual powder) and ISO standards (e.g., ISO 10993-10 for sensitization, 10993-11 for systemic toxicity, 10993-23 for irritation) for medical examination gloves. These are objective, measurable physical properties and biological responses.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

• Not Applicable: No training set exists for this type of device.

In summary, for medical gloves, the regulatory acceptance and "proof" of performance revolve around rigorous non-clinical bench testing and biocompatibility assessments against established international standards, rather than clinical studies or AI/ML specific performance metrics.

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Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The provided text describes the acceptance criteria and the study results for the "Disposable Medical Rubber Examination Gloves" (K221374) device.

Here's the breakdown of the requested information:

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

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 Physical Dimension, Physical Property, Freedom From Holes, Powdered Glove, and Extractable Protein Tests: The sample sizes are specified by the ASTM standards and AQL levels. For example:
  • Physical Dimensions: Inspection Level S-2, AQL 4.0 (This implies a sampling plan defined by ASTM D3578-19, which would dictate the sample size based on lot size).
  • Physical Property Characteristics: AQL 4.0 (similar to above).
  • Freedom From Holes: Inspection Level I, AQL 2.5 (implies a sampling plan as per ASTM D5151-06).
  • Powdered Glove Test: N=5 (5 gloves were tested for residual powder).
  • Extractable Protein Test: N=3 (3 samples were tested for extractable protein).
• Sample Size for Biocompatibility Tests:
  • Acute Systemic Toxicity: ICR mice (number not specified, but typically a standard number per group as per ISO 10993-11).
  • Skin Irritation: Rabbits (number not specified, but typically a standard number as per ISO 10993-23).
  • Skin Sensitization: Guinea pigs (number not specified, but typically a standard number as per ISO 10993-10, using the Guinea Pig Maximization method).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they are "bench tests" and "nonclinical tests" conducted for the subject device manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd. in China.

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 document describes performance testing of a physical medical device (examination gloves) against established engineering and biocompatibility standards, not an AI/imaging device requiring expert interpretation for ground truth.

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

This information is not applicable for the same reason as point 3. The device under review is an examination glove, and its performance is determined by objective physical and chemical tests, not by human interpretation or 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

This information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.

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

This information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.

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

The "ground truth" for the performance of the Disposable Medical Rubber Examination Gloves is established by:

• International Standards: Primarily ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties and dimensions, and various ISO 10993 series standards for biocompatibility (ISO 10993-11 for systemic toxicity, ISO 10993-23 for irritation, ISO 10993-10 for sensitization).
• Objective Test Methods: Laboratory tests as described (e.g., steel ruler and thickness measurement apparatus for dimensions, dumbbell/straight section specimens for physical properties, water leakage for holes, gravimetric methods for residual powder, modified Lowry Method for protein content).
• Animal Models: For biocompatibility tests (ICR mice for acute systemic toxicity, rabbits for skin irritation, guinea pigs for skin sensitization).

8. The sample size for the training set

This information is not applicable. The device is a physical product (examination gloves), not a software algorithm that requires a training set. The performance is based on manufacturing and testing against established standards.

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

This information is not applicable for the same reason as point 8.

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The Disposable medical surgical mask is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

The Disposable medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.

The Disposable medical surgical mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated steel wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The acceptance criteria and device performance for the "Disposable medical surgical mask" (K212097) are detailed in the provided tables.

1. Table of Acceptance Criteria and Reported Device Performance

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The Vinyl compound examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, Vinyl compound examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is Blue. The design of proposed device is addressing the standards as ASTM D6124. ASTM D5151, and ASTM D5250. The proposed device is not provided as sterilized. The proposed device is made of vinyl chloride.

This document is a 510(k) premarket notification for "Vinyl compound examination gloves." It focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness or diagnostic accuracy of an AI device. Therefore, many of the requested categories related to AI studies, ground truth, expert adjudication, and comparative effectiveness are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

The provided document is a 510(k) summary for a medical device: "Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical benefit. Therefore, the information provided relates to performance against recognized standards and comparison to predicates, not a traditional clinical study with human readers or training sets as might be seen for AI algorithms.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance information in Tables 2, 3, and 4 (starting on page 6), comparing the proposed device to predicate devices and referencing ASTM and ISO standards for acceptance criteria.

Differences noted and addressed:

• Length (Analysis 1): The proposed device has a different length than the predicate, but test results according to ASTM 5250 showed it meets standard requirements.
• Colorant (Analysis 2): The proposed device is clear/non-colored, while one predicate is white, blue, or yellow. The submission argues that color difference does not affect safety and effectiveness, supported by biocompatibility testing (ISO 10993-5 and ISO 10993-10).
• Ultimate Elongation (Analysis 3): The proposed device has a different ultimate elongation value than the predicate, but test results according to ASTM 5250 showed it meets standard requirements.

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

• Sample Size: The document does not explicitly state the sample size for each specific test (e.g., number of gloves tested for tensile strength, freedom from holes, etc.). However, it refers to standards such as ISO 2859-1:1999 ("Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection"), which would dictate the appropriate sample sizes for quality control testing based on lot size and AQL levels. For example, for "Freedom from Holes," an AQL of 1.5 is specified, which implies a specific sampling plan from ISO 2859-1.
• Data Provenance: The tests were conducted by the "HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD." in China, as indicated by the sponsor's identification. These are non-clinical (bench) tests supporting the device's conformance to established industry standards. The data is thus generated internally by the manufacturer for the purpose of this submission.
• Retrospective or Prospective: These are laboratory/bench tests that are inherently "prospective" in the sense that they are performed on manufactured product samples to demonstrate compliance with specifications.

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 to this type of device submission. The "ground truth" for medical gloves is established by predefined engineering specifications and performance criteria codified in international standards (e.g., ASTM D5250, ISO 10993 series). The tests are evaluated against these objective numerical or qualitative criteria, not by expert consensus in a clinical context.

4. Adjudication method for the test set:

Not applicable. This device is evaluated against objective technical standards (ASTM, ISO). There is no "adjudication" of expert opinions for a test set in this context.

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

Not applicable. This submission is for single-use medical examination gloves, which are not AI-enabled devices and do not involve human readers interpreting diagnostic images.

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

Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that it meets physical and biocompatibility specifications on its own, without requiring human interpretation for its intended function.

7. The type of ground truth used:

The "ground truth" for this device's performance is defined by the objective, measurable parameters and criteria stipulated in the referenced international standards:

• ASTM D6124 (Residual Powder)
• ASTM D5151 (Detection of Holes)
• ASTM D5250 (Poly(vinyl chloride) Gloves for Medical Application)
• ISO 10993-10 (Irritation and Skin Sensitization)
• ISO 10993-5 (In Vitro Cytotoxicity)
• ISO 2859-1 (Sampling Procedures)

These standards specify the methods for testing and the acceptable limits or qualities (e.g., minimum tensile strength, maximum powder content, AQL for freedom from holes, non-irritant/non-sensitizer for biocompatibility).

8. The sample size for the training set:

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

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

Not applicable. This is not a machine learning or AI device.

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The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device, Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes

The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, based on the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against specific ASTM standards for various properties and against a predicate device (K163146) for comparison. The key acceptance criteria and reported performance for critical aspects are as follows:

Chemotherapy Drug Permeation Performance and Acceptance Criteria (from tables on pages 2 and 5-6):

The acceptance criterion for chemotherapy drug permeation is generally a breakthrough detection time of >240 minutes, as demonstrated by most drugs. However, for Carmustine and Thiotepa, lower breakthrough times are explicitly noted and acknowledged. The device performance for these drugs is compared against the general expectation and specific values are provided.

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

The document does not explicitly state the exact sample size for each specific test. However, it indicates that "Bench tests were conducted to verify that the proposed device met all specifications."

• Sample Size: Not explicitly stated as a numerical value for each test. The adherence to standards like ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978, ISO 2859-1, ISO 10993-10, and ISO 10993-5 implies that appropriate sample sizes, as dictated by these standards, were used for testing various properties (e.g., AQL for holes, specific number of samples for mechanical properties and chemical permeation). ISO 2859-1 specifically relates to "Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," indicating a quality control sampling approach for certain attributes.
• Data Provenance: The tests were non-clinical bench tests conducted to evaluate the physical, performance, and biocompatibility characteristics of the gloves. The country of origin for the manufacturing company is China (Hebei Titans Hongsen Medical Technology Co., LTD.). The submission is for a medical device (gloves), and the testing appears to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate compliance with standards.

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

This type of information is not applicable to this submission. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO). The "ground truth" here is the pass/fail criteria defined by these objective engineering and material science standards, not subjective human interpretations or expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective, standardized test methods with clear pass/fail criteria, not on subjective expert review requiring 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

This is not applicable. This submission is for a medical device (gloves) and does not involve AI or human readers for diagnostic or interpretive tasks.

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

This is not applicable. This submission is not for an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific and engineering standards and their predefined pass/fail criteria. These include:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties).
• ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D6978-05: Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical permeation).
• ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
• ISO 10993-10: 2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
• ISO 10993-5:2009: Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.

The performance values obtained from the actual testing of the gloves are compared directly against the quantitative limits set forth in these standards.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (gloves) and does not involve a "training set" in the context of machine learning or AI models.

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

This is not applicable for the same reason as point 8.

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