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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.

Ask a specific question about this device

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

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.

Ask a specific question about this device