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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 and Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. Inner surface of gloves undergoes 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 premarket notification (510(k)) for the Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant. The focus of the study is on the non-clinical performance testing of the gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against several standards, including ASTM D6319, ASTM D6124, ASTM D412, ASTM D3767, ASTM D5151, and ASTM D6978, as well as ISO 10993 for biocompatibility.

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

The document primarily describes non-clinical testing.

• For the watertight test, the sample size used was 500 pieces.
• Specific sample sizes for other tests like physical properties, dimensions, residual powder, and biocompatibility are not explicitly stated in quantity, but imply a representative sample was tested to meet the ASTM and ISO standards.
• The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, WRP Asia Pacific Sdn Bhd, based in Malaysia. The studies are prospective as they are testing the new device.

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

This information is not applicable as the document describes non-clinical performance testing of medical gloves against established engineering and biological standards, not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is defined by the specific test methods and their measurable endpoints (e.g., breakthrough time, tensile strength values).

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical performance testing against objective standards, not subjective assessments requiring adjudication by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

This information is not applicable. The device is a medical glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.

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

This information is not applicable. The device is a medical glove, and no algorithm or AI component is involved.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on established industry standards and regulatory requirements, including:

• ASTM standards (e.g., ASTM D412, D3767, D5151, D6124, D6978) for physical properties, dimensions, watertight integrity, residual powder, and chemical permeation.
• ISO 10993 standards for biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity, acute systemic toxicity).
  These standards define objective, measurable criteria for the glove's performance.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. Performance is evaluated against pre-defined, physical, and chemical standards.

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

This information is not applicable due to the absence of a training set for this device. The "ground truth" for evaluating the glove's performance is established by the methodologies and specified outcomes mandated by the referenced ASTM and ISO standards.

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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.

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

*WARNING: Do not use Carmustine and ThioTepa.

Not Found

This document is a 510(k) premarket notification for a medical device, specifically Powder Free Nitrile Surgical Glove, Sterile, Tested For Use With Chemotherapy Drugs. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested details about acceptance criteria, test sets, experts, and ground truth are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a surgical glove.

However, based on the provided text, we can extract information regarding the device's performance against specific standards:

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

The acceptance criteria here are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is presented in the table provided in the "Indications for Use" section. For most drugs, the performance exceeds 240 minutes, with the notable exception of Carmustine and ThioTepa.

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 specify the sample size for the testing of the chemotherapy drug permeation. It is a standard test defined by ASTM D6978, which would outline the appropriate sample size. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. This testing is typically prospective, performed on newly manufactured batches of gloves.

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 question is not applicable. The "ground truth" here is the measured breakthrough time of chemotherapy drugs through the glove material, determined by laboratory testing according to ASTM D6978. It does not involve expert medical opinion or consensus.

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

This question is not applicable. Adjudication methods are typically used when human judgment is involved in establishing a ground truth, such as in clinical studies with expert readers. Here, the "truth" is an objective measurement from a standardized test.

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. This document is for a physical medical device (surgical gloves) and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve an algorithm.

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

The ground truth used is objective measurement based on a standardized laboratory test (ASTM D6978). The breakthrough detection time is a direct measurement of how long it takes for a chemotherapy drug to permeate through the glove material.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of testing the performance of a physical device like a surgical glove against a standardized permeation test.

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

This question is not applicable, as there is no training set mentioned in this context.

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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 Nitrile Patient Examination Glove, Non-Sterile (Orange) 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 is a 510(k) premarket notification for a medical device: "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)" manufactured by WRP Asia Pacific Sdn Bhd.

Based on the provided information, the acceptance criteria and the study that proves the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D412-16) would specify the required sample size.
• Dimension: Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D3767 - 03(2014)) would specify the required sample size.
• Watertight:
  • Sample Size: 315 pieces
  • Data Provenance: The data is from non-clinical testing performed on the device itself. The country of origin of the data is not specified, but the manufacturer is WRP Asia Pacific Sdn Bhd in Malaysia. This is prospective testing on the manufactured device.
• Residual Powder:
  • Sample Size: 5 pieces
  • Data Provenance: Non-clinical testing on the device. Country of origin not specified, manufacturer is Malaysian. This is prospective testing.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): These tests were performed, and results indicated "Passes" or "Not a primary skin irritant/contact sensitizer" or "Exhibit severe cytotoxicity reactivity at 100%, 66%, and 44% extract concentration. Moderate cytotoxicity reactivity at 30%, mild cytotoxicity reactivity at 20% and slight cytotoxicity reactivity at 15% extract concentrations." and "It is concluded that the extracts (polar and non-polar) of the product did not show any systemic toxicity." The exact number of samples (and animals for in-vivo tests) used for these biocompatibility tests is not detailed in the provided summary, but the standards (ISO 10993 series and Consumer Product Safety Commission regulations) would dictate the sample sizes. Data provenance is non-clinical testing on the device.

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

This document describes non-clinical performance testing of a physical medical device (gloves). The "ground truth" for these tests is established by published, internationally recognized standards (ASTM, ISO, FDA 21 CFR, CPSC regulations) and the objective measurements derived from these tests. These studies do not involve human experts establishing a subjective ground truth, as would be the case for AI/diagnostic imaging devices. Therefore, this information is not applicable.

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

Not applicable. This is not a study involving subjective human interpretation that would require an adjudication method. The testing involves objective physical and chemical measurements against pre-defined standards.

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 510(k) submission for a physical medical device (examination gloves), not an AI/Software as a Medical Device (SaMD) that would typically involve human readers or AI assistance.

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

Not applicable. This is for a physical medical device.

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

The "ground truth" for the performance characteristics of these gloves is defined by:

• Standardized Test Methods: ASTM D412-16, ASTM D3767 - 03(2014), ASTM D5151-06, ASTM D6124-06.
• Regulatory Standards: FDA 21 CFR 880.6250.
• Biocompatibility Standards: ISO 10993-10:2002(E), ISO 10993-5:2009 (E), ISO 10993-11:2017 (E), and Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.

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

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable. No training set is involved.

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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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.
Carmustine (BCNU) 3.3mg/ml 30.4
Cisplatin 1.0mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Dacarbazine 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Thiotepa 10.0mg/ml 59.0
Vincristine Sulfate 1.0mg/ml > 240

CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.

Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.

The powder free nitrile surgical glove 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 with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.

This document describes the acceptance criteria and performance study for the Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823).

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against ASTM standards for various characteristics and against the ASTM D6978-05 standard for chemotherapy drug permeation.

Note regarding Chemotherapy Drug Permeation: For Carmustine and Thiotepa, a "CAUTION" statement is included, indicating average breakthrough times of 30.4 minutes and 59.0 minutes, respectively. This implies that while the glove offers some protection, it is not indefinitely resistant to these specific drugs, and users should be aware of these breakthrough times. The other listed drugs showed breakthrough times greater than 240 minutes, indicating high resistance under the tested conditions.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for watertightness, number of samples for chemotherapy permeation). However, it indicates adherence to relevant ASTM standards (D3577-09, D6978-05, D5151-06, D6124-06) and ISO standards (ISO 10993-10), which would dictate appropriate sample sizes for these types of tests.

The data provenance is not explicitly stated in terms of country of origin for the testing, but the submitter is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing adheres to international and US standards (ASTM, ISO, 21 CFR), suggesting a globally recognized testing methodology. The studies are non-clinical performance tests.

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

This information is not applicable as the ground truth for medical gloves is established through objective physical, chemical, and biological testing against established international and national standards (ASTM, ISO, FDA regulations). There is no mention of human expert assessment or consensus being used to establish a "ground truth" for the device's performance characteristics in the way it might be for diagnostic AI.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements and compliance with predefined standards, not on human interpretation or adjudication of subjective data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes the testing of a medical device (surgical glove) based on its physical properties and resistance to chemicals, which does not involve human readers interpreting data alongside an AI.

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

This is not applicable. The device is a physical product (surgical glove), not an AI algorithm. Its performance is measured directly through laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Performance against established standards: This includes physical property measurements (tensile strength, elongation, dimensions), impermeability (watertightness), chemical resistance (chemotherapy drug permeation), cleanliness (powder-free), and biocompatibility (skin irritation, sensitization) as defined by ASTM and ISO standards and FDA regulations.
• The metrics are objective and quantitatively measured (e.g., length in mm, breakthrough time in minutes, mg/glove for powder, MPa for tensile strength).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is likely subject to quality control and statistical process control, which involves ongoing testing and process adjustments, but this is distinct from an AI training set.

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

This is not applicable for the reason stated in point 8.

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