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A Nitrile 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 specialty gloves were tested for use with Chemotherapy drugs and Fentanyl.

POWDER FREE NITRILE EXAMINATION GLOVE - Blue, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL

The provided document is a 510(k) premarket notification letter from the FDA for a Powder Free Nitrile Examination Glove. It does not contain information about an AI/ML device or a study proving its performance against specific acceptance criteria in the context of AI.

The document discusses the regulatory classification of the glove, its intended use (preventing contamination between patient and examiner), and its testing for use with chemotherapy drugs and Fentanyl. The table provided lists "Breakthrough Detection Time in Minutes" for various chemotherapy drugs and Fentanyl Citrate, which are performance metrics for the glove's barrier properties, not for an AI/ML device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the document does not pertain to an AI device.

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

Powder Free Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves 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 and it is a single use device.

The document describes the non-clinical testing of a "Powder Free Nitrile Examination Glove - Black, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Cytotoxicity: While the initial cytotoxicity test resulted in a "Fail" due to the observed cytotoxic effect in vitro, an additional in vivo Acute Systemic Toxicity test was conducted, which passed. The conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate devices K190942," implying that the comprehensive biocompatibility assessment led to an acceptable safety profile.

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

• Physical Properties (Tensile Strength & Elongation): Specific sample size not explicitly stated, but tests were conducted according to ASTM D412, which defines sampling procedures.
• Dimensions: Not specified. ASTM D3767 is referenced, implying adherence to its sampling guidelines.
• Watertight (Hole Detection): A sample size of 315 pieces was drawn from a batch size of 150,001 to 500,000.
• Residual Powder: A sample size of 5 pcs was used.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization): Not explicitly stated, but typically involves a certain number of animal subjects (e.g., guinea pigs as mentioned for dermal sensitization). Testing was done according to ISO 10993-10.
• Biocompatibility (Cytotoxicity - MEM Elution): Not explicitly stated, but tested according to ISO 10993-5. In vitro test.
• Biocompatibility (Acute Systemic Toxicity): Not explicitly stated, but involved Swiss albino mice, tested according to ISO 10993-11.

Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be generated from non-clinical laboratory testing performed by or for the manufacturer, Hong Seng Gloves Sdn Bhd, which is based in Malaysia. The studies are prospective in nature, as they involve testing the subject device to evaluate its performance against established standards.

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 as the document describes non-clinical laboratory testing of a medical device (gloves), not studies that rely on expert interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by established performance standards (e.g., ASTM, ISO) and laboratory measurements.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on medical findings. Here, the assessment is based on objective laboratory measurements against predefined 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:

This information is not applicable. This document pertains to the regulatory submission for a medical device (examination gloves) and describes non-clinical performance testing. It 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 information is not applicable. This document describes the performance of a physical medical device (examination gloves), not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established by international and national standards (e.g., ASTM D6319, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ISO 10993 series) and their defined acceptance criteria. These standards provide objective, measurable parameters (e.g., minimum tensile strength, maximum powder residue, AQL for watertightness, non-toxic response) that the device must meet.

8. The Sample Size for the Training Set:

This information is not applicable. This document describes the testing of a manufactured product against specified standards, not the development or training of a machine learning model. There is no "training set" in this context.

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

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

The powder free nitrile examination glove is manufactured from nitrile 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 is a 510(k) premarket notification for a medical device: a powder-free nitrile examination glove. It demonstrates substantial equivalence to a predicate device, not the performance of an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/diagnostic study is not applicable to this document.

For context, here's what aspects of a glove would be tested and reported on, which is very different from an AI/diagnostic device:

Acceptance Criteria and Device Performance (for a glove, as per the document):

Here's why the other requested information is not present in this document:

1. Sample size used for the test set and the data provenance: For a physical product like a glove, "test set" refers to the number of gloves sampled for various physical and chemical tests (e.g., 315 for watertightness, 5 for residual powder). This is not a "data provenance" in the sense of patient data; the "data" comes from the physical product itself. The provenance would be the manufacturing site (Malaysia). These are product quality tests, not clinical studies.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a glove relies on standardized test methods (ASTM, ISO) and laboratory measurements of physical properties, not expert human interpretation.
3. Adjudication method: Not applicable for physical product testing.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: "No clinical study is included in this submission" (Page 13). This type of study is relevant for diagnostic devices (especially AI-powered ones) to assess human performance with and without AI assistance, not for a simple examination glove.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
6. The type of ground truth used: For this device, "ground truth" is established through adherence to recognized international standards for glove manufacturing and testing (e.g., ASTM, ISO standards). For biocompatibility, it's lab test results (e.g., cytotoxicity, irritation, sensitization).
7. The sample size for the training set: Not applicable. This is a physical product, not an AI model that requires a training set.
8. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is a regulatory submission for a physical medical device (examination glove) demonstrating substantial equivalence, not a study validating an AI/diagnostic device. Therefore, the specific criteria for assessing an AI/diagnostic device's performance are not found in this type of document.

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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 Examination Glove - Blue, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile 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 is a 510(k) Premarket Notification from the FDA for a Powder Free Nitrile Examination Glove. It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of acceptance criteria and the reported device performance

The relevant table is "Table 1" and the "Summary of Non-Clinical Testing" section. They outline the acceptance criteria, primarily based on ASTM standards, and the performance of the device and the predicate device.

The "Comparison Analysis" column in Table 1 notes that some characteristics (Tensile Strength, Ultimate Elongation, Thickness, Powder Free) are "Different but within the ASTM standard," indicating they meet the acceptance criteria despite not being identical to the predicate device.

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

• Physical Properties (Tensile Strength, Elongation): Sample size is not explicitly stated for these tests within the provided text, but it commonly involves multiple samples to determine average values. The data provenance is implied to be from Hong Seng Gloves Sdn Bhd, Malaysia, as they are the submitter and manufacturer. This is retrospective testing done by the manufacturer to demonstrate compliance.
• Watertight:
  • Sample size: 500 pieces were tested. The batch size for this sampling was 150,001 to 500,000, and according to the single sampling plan G1, the sample drawn was code M equivalent to 315 pieces, but 500 pcs were tested.
  • Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia), as part of their non-clinical testing. This is retrospective testing.
• Powder Free:
  • Sample size: 5 pieces (as stated in the "Summary of Non-Clinical Testing" table under "Results" for Powder Free).
  • Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia). Retrospective testing.
• Dimension:
  • Sample size: Not explicitly stated for each size, but dimension measurements would typically involve multiple gloves per size.
  • Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia). Retrospective testing.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): Sample sizes for biological tests (e.g., number of animals for irritation/sensitization, cell cultures for cytotoxicity) are not specified, but the tests were performed "under the conditions of the study" and passed relevant ISO standards.
  • Data Provenance: These are specified as being performed according to ISO standards, implying accredited lab testing, likely commissioned by the manufacturer. Retrospective testing.

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

This document describes a 510(k) submission for a Class I medical device (examination glove). The ground truth for this type of device is established through performance against recognized industry standards (e.g., ASTM, ISO).

• No human "experts" in the sense of clinicians or radiologists are used to establish ground truth for performance testing in this context. The ground truth is objective, quantifiable measurements against pre-defined engineering and safety standards.
• Therefore, the concepts of "number of experts" and "qualifications of those experts" (like radiologists with 10 years of experience) are not applicable to the non-clinical performance testing described here.

4. Adjudication method

• As the ground truth is established by objective measurements against ASTM/ISO standards, there is no adjudication method (like 2+1 or 3+1 consensus) required for these types of tests. The results are quantitative and directly compared to the numerical acceptance criteria.

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

• No MRMC study was performed. This device is a physical examination glove, not an AI-powered diagnostic tool or an imaging device. The concept of "human readers improving with AI assistance" is entirely irrelevant to this product submission.
• The document explicitly states: "No clinical study is included in this submission."

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

• Not applicable. This device is an examination glove, not an algorithm. There is no "algorithm only" performance to evaluate.

7. The type of ground truth used

• The ground truth used for this device's performance evaluation is based on established national and international consensus standards for physical properties and biocompatibility of medical gloves, specifically:
  • ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application
  • ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves
  • ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves
  • ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (presumably variations are used for physical properties before/after aging)
  • ASTM D3767: Standard Practice for Rubber--Measurement of Dimensions
  • ISO 10993-10:2010 (E): Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
  • ISO 10993-5:2009 (E): Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-11:2017 (E): Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
  • Medical Glove Guidance Manual – Labeling

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device (a glove) and does not involve AI or machine learning algorithms that require a "training set." The testing outlined is for product quality and safety validation, not algorithm development.

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

• Not applicable. See point 8.

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