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

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

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

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

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

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

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

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

Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

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

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

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

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

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Study Proving Device Meets Acceptance Criteria:

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

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

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

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

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

4. Adjudication method for the test set

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

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

• Not applicable. This is a submission for medical gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

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

7. The type of ground truth used

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

8. The sample size for the training set

• Not applicable. This device is a physical product (gloves) and does not involve machine learning or AI, thus there is no "training set."

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

• Not applicable, as there is no training set for this device.

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

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

This document describes the acceptance criteria and performance of "Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile" as part of a 510(k) summary for FDA approval.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for watertightness, tensile strength, etc.). However, it refers to compliance with ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10:2010(E). These standards typically specify the appropriate sampling plans and sample sizes required for testing.

The data provenance is Malaysia, as the submitter, WRP Rubber Products Sdn Bhd, is located in Sepang, Selangor Darul Ehsan, Malaysia. The data would be considered prospective in the sense that WRP Rubber Products Sdn Bhd conducted these tests for the purpose of their 510(k) submission, likely on batches of the device intended for market.

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

This information is not applicable in this context. The provided document is for a medical device (examination gloves) that relies on engineering and biological performance standards, not diagnostic interpretative tasks. The "ground truth" is established by adherence to defined technical specifications and results from laboratory testing, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review processes, such as in clinical trials or image interpretation studies where discrepancies between initial assessments need to be resolved. For performance testing against objective standards, the results are typically quantitative and directly compared to the specified criteria without a need for expert 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 concerns the regulatory approval of patient examination gloves, which are physical medical devices, not AI-powered diagnostic or assistive tools. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.

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

This information is not applicable. As stated above, this document is for a physical medical device (examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by objective, standardized laboratory test results compared against predefined technical specifications and regulatory standards. For example:

• Dimensions: Measured values compared against minimum length and target width.
• Physical Properties (Tensile Strength, Elongation): Measured values compared against minimum performance criteria before and after aging.
• Powder Free: Measured amount of powder compared against a maximum limit (≤ 2 mg/glove).
• Watertight: Result of water leak test compared against the AQL 2.5 standard.
• Biocompatibility: In-vivo (likely animal) or in-vitro tests demonstrating lack of irritation or sensitization as per ISO 10993.

These are verifiable, quantitative, and qualitative outcomes from standardized test methods.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning models. This product is a physical medical device and does not involve AI or machine learning, thus no training set is relevant.

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

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

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

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

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

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

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

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

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

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. For example:

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

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

8. The sample size for the training set

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

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

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

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The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.

Powder Free Nitrile Examination Gloves, Blue meet all the requirements of ASTM standard D6319-00a, D6124-06 and FDA 21 CFR 880.6250.

Acceptance Criteria and Device Performance Study for DERMAGRIP ULTRA Powder Free Blue Nitrile Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size used for each specific test within the "Non-Clinical Performance Data" section. However, medical device testing, particularly for gloves, involves sampling from production lots. The results are reported as meeting the specified ASTM standards, which themselves define sampling plans and acceptable quality limits (AQL) for various tests.

The data provenance is not specified in terms of country of origin, but the submitter is from Malaysia (Advance Medical Products Sdn Bhd). The study appears to be retrospective, relying on performance data generated during the product development and quality assurance process, rather than a new prospective clinical study.

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

The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The ground truth for this device (examination gloves) is established by adherence to recognized international and national standards (ASTM, ISO, and FDA regulations). These standards are developed and maintained by expert committees in their respective fields (e.g., materials science, toxicology, medical devices).

Therefore, the "ground truth" is the defined requirements and methodologies within these standards. The device's performance is measured against these objective criteria rather than subjective expert consensus on individual cases.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are not relevant for the testing of examination gloves as described. The testing involves objective measurements to assess compliance with physical, chemical, and biological standards. Results are typically pass/fail based on predefined thresholds and statistical sampling plans outlined in the respective ASTM and ISO standards (e.g., AQL for pinholes). There is no subjective interpretation requiring an adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of a computer-aided diagnostic (CAD) device on human reader performance for tasks like image interpretation. This device is a physical medical device (examination glove), not an AI/CAD system, and its performance is evaluated against objective technical standards, not against human reader performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Device Performance" section and the "Non-Clinical Performance Data" explicitly describe tests conducted on the device itself (DERMAGRIP ULTRA Powder Free Blue Nitrile Examination Gloves) to determine if it meets the specified ASTM and ISO standards for:

• Dimensions
• Physical Properties (e.g., tensile strength, elongation)
• Thickness
• Powder content
• Biocompatibility (skin irritation and sensitization)
• Watertight integrity (pinholes)

These tests evaluate the algorithm-only performance, as the device's function is entirely self-contained within its physical properties and there is no human-in-the-loop interaction in its performance assessment beyond conducting the prescribed standardized tests.

7. Type of Ground Truth Used

The type of ground truth used is objective, standardized measurements and criteria defined by validated industry and regulatory standards. Specifically:

• ASTM (American Society for Testing and Materials) Standards: D6319-10 (for physical properties, dimensions, thickness), D6124-06 (for powder residue), D5151-06 (for watertight integrity/pinholes).
• ISO (International Organization for Standardization) Standard: ISO 10993-10:2002(E) (for dermal sensitization).
• Consumer Product Safety Commission Regulations: Title 16, Chapter II, Part 1500:41 & 1500:3 (c)(4) (for primary skin irritation).

These standards provide the pre-established, empirically validated metrics against which the device's performance is compared.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a physical medical device (examination gloves), not a machine learning or AI model that requires training data. The device's properties are inherent to its manufacturing process and materials.

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

As stated above, a "training set" is not relevant for this type of device. The "ground truth" for evaluating the performance of examination gloves is established through rigorous, standardized testing methodologies detailed in the ASTM, ISO, and CPSC regulations. These standards define how to measure the intrinsic properties of the glove and the acceptable limits for those properties to ensure safety and effectiveness for its intended use.

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