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A nitrile 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.

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

This document describes the premarket notification (510(k)) for a medical device, specifically "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". It is not an AI/ML medical device submission. Therefore, the questions related to AI/ML specific studies, such as MRMC studies, ground truth establishment by experts, and training/test set sample sizes for AI/ML models, are not applicable.

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K190942) by meeting established performance standards for patient examination gloves.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance & Comparison Analysis

The document provides a detailed comparison in "Table 1" and further test results in section "7.0 Summary of Non-Clinical Testing".

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A nitrile 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

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface 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 or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

The provided document describes the non-clinical performance testing for a medical device: "Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile." This submission is a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set (Current Device):
  • Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but tests were performed for different glove sizes (XS, S, M, L, XL). ASTM D412 and D6319 typically specify sample sizes.
  • Dimensions (Length, Width, Thickness): Not explicitly stated, but performed for all glove sizes (XS, S, M, L, XL). ASTM D3767 specifies measurement practices.
  • Watertight: 315 pieces (for a batch size of 150,001 to 500,000).
  • Residual Powder: 5 pieces.
  • Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Not explicitly stated for each test, but typically involves animal subjects (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity).
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would be prospective for this specific device.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

This document describes non-clinical performance testing of a physical medical device (gloves). The ground truth for this type of device is established through standardized laboratory tests according to recognized ASTM and ISO standards, not via expert consensus or clinical evaluation in the same way as, for example, an AI diagnostic tool. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context doesn't directly apply as it would for a clinical study or AI performance evaluation. The "experts" are implicitly the technicians and scientists performing the tests according to the defined standards.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements and evaluations against specified pass/fail criteria from recognized standards (ASTM, ISO). There is no "adjudication" between multiple human readers or interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices or imaging tools where human readers are involved in interpreting results. This submission is for a physical medical device (gloves) and focuses on non-clinical performance characteristics.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used:

The ground truth used is based on:

• Standardized Test Methods: Adherence to established and recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards.
• Quantitative Measurements: Direct measurements of physical properties (tensile strength, elongation, dimensions, powder content).
• Qualitative Assessments: Outcomes of biocompatibility tests (irritation, sensitization, toxicity) as defined by ISO standards on animal models.
• Statistical Sampling: For watertightness, an Acceptance Quality Limit (AQL) statistical sampling plan (ISO 2859) is used.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of medical device which undergoes standardized physical and chemical testing. This is not an AI or machine learning model.

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

Not applicable, as there is no training set. The device's performance is evaluated directly against pre-established, widely accepted industry standards and regulatory requirements for medical examination gloves.

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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 are designed for single use only and should be disposed after use.

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 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 provided document describes the acceptance criteria and results of a study for the "Black Nitrile Powder Free Patient Examination Glove, Non Sterile" (K212916).

Here's a breakdown of the requested information:

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

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

• Physical Properties: The document doesn't explicitly state the sample size for individual physical properties tests, but generally refers to conforming to ASTM D412.
• Watertight: The sample size for the watertight test was 315 pieces from a batch size of 150,001 to 500,000.
• Dimension: The document doesn't specify a sample size for dimensional measurements per glove size, but mentions measurement as per ASTM D6319.
• Residual Powder: The sample size for residual powder was 5 pieces.
• Biocompatibility: The sample size for biocompatibility tests is not explicitly stated in the provided text for each specific test, but they generally follow ISO and CPSC standards, which would define appropriate sample sizes for these types of biological evaluations. For Dermal Sensitization, "guinea pigs" are mentioned, and for Acute Systemic Toxicity, "Swiss albino mice" are mentioned, implying animal testing was conducted.

The data provenance is not explicitly stated as "retrospective" or "prospective." However, given that this is a 510(k) submission for a new device claiming substantial equivalence to a predicate, the tests are conducted on the subject device (K212916) in order to demonstrate its performance. The manufacturer, Rimba Glove Sdn Bhd, is located in Perak, Malaysia. The testing would have been conducted to support this submission.

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 device is a patient examination glove, a non-AI/software medical device. Therefore, the concept of "ground truth established by experts" in the context of diagnostic interpretation (like in imaging AI) is not applicable here. The "ground truth" for the performance tests (e.g., tensile strength, watertightness, dimensions, powder content, biocompatibility) is established by adherence to recognized international and national standards (ASTM, ISO), and the results are quantifiable measurements or observed biological responses as determined by standard laboratory practices.

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

Not applicable. This is not a diagnostic device involving human interpretation that would require adjudication. The test methods are objective, standardized laboratory measurements and biological assays.

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 physical medical device (examination glove) and does not involve human readers, AI, or diagnostic interpretation.

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

Not applicable. This is a physical medical device and does not involve algorithms or AI.

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

The "ground truth" for this device's performance is based on:

• Standardized Test Methods: Adherence to established industry standards like ASTM (e.g., ASTM D412, D5151, D3767, D6124, D6319) and ISO (e.g., ISO 10993 for biocompatibility).
• Quantifiable Measurements: Physical properties (tensile strength, elongation, dimensions, powder residue) are measured directly.
• Biological Responses: Biocompatibility tests (skin irritation, sensitization, cytotoxicity, systemic toxicity) are assessed based on scientific protocols for animal and in vitro tests, adhering to ISO 10993 and CPSC guidelines.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.

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

Not applicable. As there is no training set for an AI model, no ground truth was established for it.

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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.

Nitrile Powder Free Patient 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 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 ambidextrous, i.e., can be worn on right hand or left hand.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". This document focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial for novel device performance.

Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment for a diagnostic algorithm (which is typical for AI/ML device submissions) is not applicable to this specific registration. This document describes the physical and chemical properties of a medical glove.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing performed to show equivalence with existing standards for examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

Further Requested Information (Not Applicable or Not Provided for this Device Type):

The following points are specifically relevant for AI/ML-powered diagnostic or decision support devices, which is not what this FDA submission is for. This document is for a physical medical glove. Therefore, the requested information below is not present in the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a physical medical glove. The non-clinical tests involved sampling of gloves for physical and chemical property testing.
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): Not applicable. Ground truth for physical properties is established through standardized laboratory testing protocols, not expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" is defined by the technical specifications and testing methods in the ASTM and ISO standards (e.g., a hole is a hole if water leaks, tensile strength is measured by a specific test).
8. The sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

Conclusion from document:

The provided document describes the non-clinical testing of a "Black Nitrile Powder Free Patient Examination Glove, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942). The tests show that the glove meets or exceeds the requirements of relevant ASTM and ISO standards for physical properties, dimensions, watertight integrity, residual powder, and biocompatibility, thus clearing it for market. No clinical studies or AI/ML algorithm evaluations were part of this 510(k) submission.

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