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Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate 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. It is for over-the- counter use.

In addition, these gloves were tested for use with Chemotherapy Citrate in accordance with ASTM D6978-05, Standards Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device in this 510(k) Notification is a Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. The subject device is a patient examination glove made from nitrile rubber compound, Cornflower Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl citrate.

This document is a 510(k) Premarket Notification from ECO Medi Glove Sdn. Bhd. for their Cornflower Blue Powder Free Nitrile Examination Glove, which has been tested for use with chemotherapy drugs and Fentanyl Citrate. The document summarizes the device's characteristics, its intended use, and the performance criteria it meets based on non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document indicates that the device meets the acceptance criteria through non-clinical testing. These tests were conducted according to established international and national standards.

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

• Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for permeation, number of samples for physical properties, number of animals for biocompatibility). It references the standards used, which typically define the required sample sizes for such tests. For example, for "Freedom from Pinholes," it mentions "AQL 2.5, Inspection Level G-1" which implies a sampling plan based on the number of units in a lot. For "Width" and "Thickness" it references "ISO 2859-1 / S2/AQL 4.0," also indicating a sampling scheme.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, given that the manufacturer is ECO Medi Glove Sdn. Bhd. located in Taiping, Perak Darul Ridzuan, Malaysia, it is highly probable that the testing was conducted in Malaysia or contracted to a testing facility recognized in the region. The data is retrospective, as it's a summary of tests already performed for the 510(k) submission.

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

This information is not applicable in this context. The "ground truth" here is defined by objective physical and chemical measurements according to standardized test methods (ASTM, ISO). There is no "expert consensus" or "clinical ground truth" involved in evaluating the performance of examination gloves against these specific criteria. The standards themselves, developed by expert committees, define the acceptable levels.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the evaluation involves objective measurements against predefined criteria in recognized standards, there is no need for an adjudication method by human readers or experts in the way it would be for a diagnostic medical device reading images or interpreting clinical data.

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 device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is entirely 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 device is a medical glove and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established by:

• Standardized Test Methods: Adherence to widely accepted national and international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19 (for physical properties and dimensions), ASTM D5151-19 (for pinholes), ASTM D6124-06(2022) (for powder-free residue), and ISO 10993 series (for biocompatibility).
• Objective Measurement Data: The results of the tests conducted in accordance with these standards provide the "ground truth" for whether the glove meets the defined performance characteristics. For breakthrough times, it's the measured time; for physical properties, it's the quantitative values compared to minimum/maximum thresholds; for biocompatibility, it's the qualitative assessment (Pass/Fail) based on biological response.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of physical product testing for a medical glove. The testing performed is to verify the manufactured product meets defined specifications.

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

This information is not applicable for the same reason as 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19. The powder free examination glove is manufactured from synthetic rubber nitrile. 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. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile. The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.

The provided text describes the acceptance criteria and performance of "Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl". This is a medical device, specifically examination gloves, and therefore the "study" concerns non-clinical performance testing rather than studies involving human participants or AI algorithms.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• For Watertightness (ASTM D5151):
  • Small: 200 pcs
  • Medium: 315 pcs
  • Large: 315 pcs
  • Extra Large: 315 pcs
  • Double Extra Large: 200 pcs
• For other tests (Physical Properties, Dimension, Residual Powder, Biocompatibility, Chemotherapy Drug and Fentanyl Citrate Permeation): The specific sample sizes are not explicitly stated in the provided text. However, for these types of non-clinical tests, samples are typically drawn from manufacturing lots according to the requirements of the respective ASTM or ISO standards.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is a report of completed non-clinical performance and safety testing.

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. The document describes the performance of a physical medical device (gloves) through standardized non-clinical laboratory testing (e.g., tensile strength, chemical permeation) to establish its physical and chemical properties and safety. There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes for this type of device.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices or AI algorithms, to resolve discrepancies in human expert interpretations or to establish a consensus ground truth. This document pertains to non-clinical laboratory testing of a tangible product.

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 is not applicable. The device is a physical examination glove, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and there is no AI assistance involved.

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 examination glove, not an algorithm, so there is no standalone algorithm performance to evaluate.

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

The "ground truth" for this device's performance is established by the accepted methodologies and metrics defined in the referenced ASTM and ISO standards for physical, chemical, and biocompatibility testing. For example:

• Physical properties (tensile strength, elongation) are measured objectively using a Tensile Testing Machine.
• Dimension (length, width, thickness) is measured using appropriate measurement tools.
• Watertightness is determined objectively by inspecting for holes after filling with water.
• Chemical permeation is physically measured based on the detection time of breakthrough.
• Biocompatibility is assessed through standardized in-vitro or in-vivo (animal) tests specified by ISO 10993 standards.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense of a diagnostic or therapeutic device for this type of product.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning model, so 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 a physical product.

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