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Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are 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 drugs, Fentanyl, and Gastric Acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I) and come in eight sizes (XXS, XS, S, M, L, XL, and XXL). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves and Modified Draize Test. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, fentanyl, and Gastric Acid.

The provided document is a 510(k) Premarket Notification for a medical device: "Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid."

The document details the technical characteristics and performance of the device through various tests, often comparing it to predicate devices. It describes the acceptance criteria and study results primarily for the physical and chemical resistance properties of the gloves, as well as biocompatibility testing.

However, it's crucial to note that this document DOES NOT describe a study involving an AI or algorithm-driven device (e.g., for image analysis or disease detection). Therefore, many of the specific questions about human readers, AI assistance, ground truth establishment for AI training, and expert adjudication are not applicable to this type of device and study.

The study described is a non-clinical performance and chemical permeation study of a physical medical device (gloves), not an AI/ML-driven diagnostic or therapeutic system.

Given this, I will describe the acceptance criteria and the study that proves the device meets them based only on the information available in the provided document, acknowledging the non-applicability of AI/ML-specific questions.

Acceptance Criteria and Device Performance for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (K233560)

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed against recognized ASTM and ISO standards for medical gloves, primarily focusing on physical properties, freedom from defects, biocompatibility, and resistance to chemical permeation.

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

• Physical and Chemical Resistance Tests: The document does not specify the exact sample sizes for each physical or chemical permeation test. However, these tests are generally performed on a sufficient number of glove samples to meet the requirements of the specified ASTM standards (e.g., ASTM D5151 for pinholes usually involves a large number of gloves for AQL testing).
• Biocompatibility / Modified Draize-95 Test (Low Dermatitis Potential Claim):
  • Sample Size: 211 subjects initially recruited, with 205 subjects completing the two stages of the study (6 subjects discontinued due to poor compliance).
  • Data Provenance: Not explicitly stated (e.g., country of origin), but the study was performed to support a 510(k) submission to the FDA for sale in the US market. Given the manufacturer is based in Malaysia (Eco Medi Glove Sdn. Bhd.), it is plausible the study was conducted there or in a region with compatible regulatory standards.
  • Retrospective or Prospective: This was a prospective clinical study (Modified Draize-95 Test) specifically conducted to evaluate the low dermatitis potential of the device.

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

• For physical and chemical resistance tests: Ground truth is established by objective, standardized laboratory measurements based on ASTM and ISO methods. No human "experts" in the sense of adjudicating medical images or clinical outcomes are involved in establishing ground truth for these types of tests.
• For the Modified Draize-95 Test: The ground truth for skin sensitization (type IV allergy) or irritation is based on the clinical observation of the subjects' skin reactions by qualified personnel (e.g., dermatologists or trained clinical researchers) following the specified protocol (FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products" (1999) which pertains to the Modified Draize-95 Test). The document does not specify the number or specific qualifications of these observers, but it is implied they are clinical professionals capable of evaluating skin reactions.

4. Adjudication Method for the Test Set

• For physical and chemical resistance tests: No adjudication is typically needed as tests are objective measurements against defined thresholds.
• For the Modified Draize-95 Test: The nature of the Modified Draize test involves direct clinical observation for skin reactions. While not explicitly stated as "adjudication," the interpretation of skin reactions by the clinical team would constitute the "ground truth." There is no indication of multiple independent readers or complex adjudication schemes like 2+1 or 3+1 as would be seen for subjective image interpretation.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was NOT done. This type of study (comparing human readers with and without AI assistance on medical cases) is relevant for AI-powered diagnostic devices, not for physical medical devices like examination gloves.

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

• Not applicable. There is no algorithm or AI component to this device. The performance is the intrinsic material performance of the glove itself.

7. The Type of Ground Truth Used

• For physical properties: Measurement against engineering specifications and industry standards (e.g., freedom from pinholes, dimensions, tensile strength).
• For chemical permeation: Objective measurement of breakthrough time using standardized chemical testing methods (ASTM D6978-05).
• For biocompatibility (dermal irritation/sensitization): Clinical observation of human subjects for skin reactions following a standardized protocol (Modified Draize-95 Test) and in-vitro/in-vivo biological evaluations per ISO 10993. The "ground truth" is the observed biological response or lack thereof.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI/ML models that require a "training set."

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

• Not applicable. As there is no AI/ML component, there is no training set or ground truth establishment for a training set.

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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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Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that are 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 drugs and Fentanyl Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs and Fentanyl Test claim.

The subject device in this 510(k) Notification is EMG Blue Powder Free Nitrile Examination Gloves with Chemotherapy Drugs and Fentanyl Test Claim. The subject device is a patient examination glove made from nitrile latex compound, 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 test claims.

The Blue Nitrile Medical Examination Gloves, Powder Free, is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner (product Code LZA) and are used with chemotherapy drugs (Product code LZC and OPJ) and fentanyl test (Product code QDO).

The provided document is an FDA 510(k) clearance letter for a medical device: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim. This document describes the device's technical specifications and safety testing, not AI/ML algorithm development or performance in a clinical setting.

Therefore, the requested information often found in AI/ML performance studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) is not applicable to this device and is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device and confirming adherence to established physical, chemical, and biological safety standards for examination gloves.

Here's the information that is applicable and can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on various ASTM and ISO standards, primarily related to the physical properties, biocompatibility, and chemical resistance of examination gloves. The "Reported Device Performance" column reflects whether the device met these established standards.

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

• Sample Size for Test Set:
  • For "Freedom from Pinholes" and "Dimensions": "Per Lot Size 500,000pcs" and "ISO 2859-1 / S2/AQL 4.0" are mentioned, indicating statistical sampling methodology from production lots rather than a fixed "test set" in the AI/ML sense. Specific N values for testing each characteristic are not given but are implied by adherence to the ASTM/ISO standards.
  • For "Residual Powder": "Once every PO" (Purchase Order) indicates routine testing, not a specific "test set" size.
  • For Biocompatibility and Resistance to Chemotherapy Drugs/Fentanyl: The document implies standard testing procedures were followed per ISO and ASTM D6978-05. Specific sample sizes (N) for these tests are not explicitly stated within the public summary, but are defined by the referenced standards.
• Data Provenance: The manufacturer, Eco Medi Glove Sdn. Bhd., is based in Malaysia. The testing would presumably have been conducted there or by accredited labs on behalf of the manufacturer. The data is retrospective in the sense that it represents tests performed on already manufactured gloves.

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

Not applicable. This is not an AI/ML device relying on human expert consensus for ground truth. The "ground truth" here is defined by performance against objective, quantitative physical and chemical test standards (e.g., tensile strength, breakthrough time, AQL for pinholes).

4. Adjudication method for the test set

Not applicable. The "ground truth" is determined by objective laboratory measurements against defined ASTM/ISO standards, not by human interpretation requiring adjudication.

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 physical examination glove, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This device is a physical examination glove, not an AI/ML algorithm.

7. The type of ground truth used

The ground truth used consists of objective, quantitative measurements defined by international and national standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993 series, ASTM D6978-05). These standards specify the methods and acceptable ranges for physical properties (e.g., dimensions, tensile strength, elongation), chemical properties (e.g., powder residue, chemotherapy drug permeation time), and biological response (e.g., irritation, sensitization).

8. The sample size for the training set

Not applicable. This device is a physical examination glove, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical examination glove, not an AI/ML algorithm.

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Powder Free NR Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The subject device in this 510(k) Notification is Latex Surgeon's Glove Powder Free with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein. The subject device is a Surgeon's glove made from compounded primarily Natural Latex, Yellow, powder free and sterile (Per 21 CFR 878.4460, class I. The device meets all the specifications in ASTM 3577-09, Standard specification for Rubber Surgical Glove. Additionally, the gloves have been tested for biocompatibility. Latex Surgeon's Gloves Powder Free with Protein content labelling claims 50ug/dm² or less per glove of extractable Protein is classification as Type 1: Glove compounded primarily form Natural Rubber Latex The Proposed device is sterilized using Gamma irradiation method to achieve the sterility Assurance Level (SAL) of 10E and place in a sterility maintenance package to ensure a shelf life of 3 years Powder Free NR Latex Surgical Glove (Sterile), is a disposable device intended for medical purposes that is worn by operating room personal to protect a surgical wound from contamination (product Code KGO).

The provided text describes the regulatory review and approval of a medical device, specifically "Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein." It details the device's characteristics, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the request asks for information related to Acceptance Criteria and a Study that proves the device meets the acceptance criteria in the context of an AI/Machine Learning (ML) device. The provided document is a 510(k) premarket notification for a physical medical glove, not an AI/ML device.

Therefore, the document does not contain the information required to answer questions about acceptance criteria and studies for an AI/ML device. The concepts of "test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set," and "ground truth for training set" are specific to the evaluation of AI/ML models, not physical medical devices like gloves.

The document discusses:

• Acceptance Criteria for the glove: These are defined by relevant ASTM standards (e.g., D3577-09 for dimensions, physical properties, freedom from pinholes; D6124-06 for powder residue; D5151-06 for pinhole level) and biocompatibility tests (ISO 10993-10).
• Study Proving Acceptance: Non-clinical testing was performed according to these standards, and the results ("PASS") demonstrate that the device meets these criteria.
• Performance Data: Tables on pages 4, 5, 7, and 8 show the specifications and test results for dimensions, physical properties (tensile strength, elongation before and after aging), freedom from pinholes, powder residue, protein content, biocompatibility (skin irritation, sensitization, systemic toxicity), sterility, and shelf life.

In summary, while the document provides acceptance criteria and performance data for a medical glove, it is not applicable to the specific questions regarding AI/ML device evaluation.

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The Gen 2 Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contains Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

The provided text is related to the FDA 510(k) premarket notification for a medical device: "GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims." It outlines the device's characteristics, intended use, and the tests performed to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the studies mentioned, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Low Dermatitis Potential Claim (Clinical Study):

  • Sample Size:
    • Stage 1: 30 human subjects
    • Stage 2 (Total): Minimum 205 individuals (including the initial 30). The study was completed on 205 adult human subjects.
  • Data Provenance: The document states the subjects "reasonably reflect the general user population in the US." No explicit country of origin for the data collection is specified beyond this, but the company is in Malaysia, suggesting the study might have been conducted there or in the US with a US-representative population. The study is prospective, as it involves human testing for irritation and sensitization.

• Chemotherapy Drug Permeation and other ASTM/ISO tests: The document does not specify the sample size for these non-clinical tests. These tests are typically conducted on a representative number of glove samples according to the respective standard (e.g., a batch of gloves). The data provenance is industrial testing, likely from the manufacturer's quality control processes in Malaysia, as it refers to meeting ASTM standards rather than specific patient data.

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

• For the clinical study (Low Dermatitis Potential Claim): The document does not explicitly state the "number of experts" or their specific "qualifications" involved in establishing the ground truth of skin irritation/sensitization. The ground truth would be based on the clinical observations of the human subjects by qualified medical professionals conducting the Modified Draize 95 test.
• For non-clinical tests (ASTM/ISO): Ground truth is established by the test methods specified in the standards themselves, not typically by human experts reviewing individual cases. The results are quantitative measurements against defined criteria.

4. Adjudication Method for the Test Set

• For the clinical study (Low Dermatitis Potential Claim): The document does not specify an adjudication method like 2+1 or 3+1. The results are presented as direct observations ("all negative results," "no clinical evidence of... Type IV allergy"). This suggests direct observation and interpretation by the clinicians conducting the study.
• For non-clinical tests: Adjudication methods like those for interpreting medical images are not applicable here. The tests involve direct measurement against a standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a nitrile examination glove, not an AI-powered diagnostic algorithm or imaging device that would typically involve human readers.

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

This refers to a standalone performance study of the device itself.

• Yes, for the physical and chemical properties: The ASTM and ISO standard tests (e.g., tensile strength, pinholes, chemotherapy drug permeation, biocompatibility) are standalone evaluations of the glove material and design performance. They are conducted without human intervention in the loop other than performing the test itself.
• Yes, for the clinical dermatological claim: The Modified Draize 95 Test is a standalone assessment of the glove's potential to cause skin irritation or sensitization on human subjects.

7. The Type of Ground Truth Used

• Low Dermatitis Potential Claim: Clinical observation / Outcomes data (absence of irritation/sensitization in human subjects after exposure).
• Chemotherapy Drug Resistance: Laboratory measurement against established permeation thresholds (quantitative data defined by ASTM D6978-05).
• Physical Properties (Tensile Strength, Elongation, Dimensions, Pin-holes): Laboratory measurement against specified physical standards (quantitative data defined by ASTM D6319-10 and ASTM D5151-06).
• Powder-free Residue: Laboratory measurement (quantitative data defined by ASTM D6124-06).
• Biocompatibility (Cytotoxicity): Laboratory measurement (quantitative or qualitative data defined by ISO 10993-5).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is not an AI/machine learning device. The studies described are for validation/testing of the final product.

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

Not applicable, as there is no training set for this type of medical device.

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The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.

The provided document describes the safety and performance characteristics of a Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K181066), rather than an AI/ML powered medical device. Therefore, much of the requested information (e.g., AI/ML specific acceptance criteria, sample sizes for test/training sets, ground truth establishment methods, MRMC studies, standalone performance studies) is not applicable or available within this document.

However, I can extract and present the available information regarding the glove's acceptance criteria and the studies conducted to demonstrate its performance against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Chemical Tests: The document refers to compliance with various ASTM standards (D6319-10, D5151-06, D6124-06, D6978-05). These standards prescribe specific sampling plans and test methods. The exact sample sizes used for each of these physical and chemical tests are not explicitly stated in this summary. The data provenance would be from laboratory testing according to these standards.
• Biocompatibility/Low Dermatitis Potential Claim:
  • Sample Size: A total of 205 human subjects were tested for the Modified Draize-95 test. This involved an initial population of 30, with a further number added to reach 205.
  • Data Provenance: The study was a prospective human subject test conducted to evaluate the potential for irritation or sensitization. The document states the subjects "reasonably reflect the general user population in the US." The country of origin of the data is not explicitly stated, but the mention of "human subjects...in the US" could imply the study was conducted there, or at least designed to reflect a US population's response.

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

• For the physical and chemical tests (e.g., tensile strength, pinholes, chemotherapy drug permeation), the "ground truth" is established by the direct measurement or observation of the glove's performance against the objective criteria set by the ASTM standards. No human consensus "experts" are typically involved in establishing this type of ground truth beyond the trained personnel performing the tests according to the standard operating procedures.
• For the Low Dermatitis Potential Claim, the "ground truth" was established by the clinical observations of the 205 human subjects during the Modified Draize-95 test. The document states, "The study completed on 205 non sensitized adult human subjects... gave all negative results. There was no clinical evidence of the presence of residual chemical additives that may induce Type IV allergy..." This implies clinical evaluation by medical professionals, but the number and specific qualifications of these experts are not provided in the document.

4. Adjudication Method for the Test Set

• For the physical and chemical tests, adjudication is based on whether the measured values meet the specified criteria in the ASTM standards.
• For the Low Dermatitis Potential Claim via the Modified Draize-95 test, the outcome ("all negative results," "no clinical evidence") suggests a direct observation and interpretation by clinical evaluators rather than a formal multi-reader adjudication process like 2+1 or 3+1. The methodology would follow the specified FDA guidance document referenced.

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 document describes a medical glove, not an AI/ML powered device. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or reported.

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

• Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no standalone algorithm performance study was conducted or reported.

7. The Type of Ground Truth Used

• Objective Measurement/Standard Compliance: For physical properties (dimensions, tensile strength, elongation, pinholes, residual powder) and chemotherapy drug resistance, the ground truth is based on direct laboratory measurements and adherence to established ASTM standards.
• Clinical Observation: For the biocompatibility claims (primary skin irritation, dermal sensitization, cytotoxicity) and the low dermatitis potential claim, the ground truth is based on clinical observations and laboratory assays as per ISO 10993-10:2010, ISO10993-5, 16 CFR Part 1500.41, and the Modified Draize-95 test results on human subjects.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Not Applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.

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A powder-free patient examination glove is a disposable device intended for use medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and use for use with chemotherapy drugs.

In addition these gloves were tested for use with chemotherapy drugs in accordance ASTM D6978-05 standards- Practice for assessment of Medical Glove to Permeation by chemotherapy drugs

The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.

The Blue Nitrile Medical Examination Gloves ,Powder Free, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC).

The document describes the acceptance criteria and performance of the "EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs." This is a medical device, not an AI/ML device, so many of the requested fields are not applicable.

Here's the information extracted and formatted as requested, with "N/A" for fields that are not relevant to this type of device:

Acceptance Criteria and Device Performance for EMG Blue Nitrile Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Physical/Chemical Tests: Not explicitly stated as a single number. The testing is based on ASTM standards (D6319-10, D5151-06, D6124-06) which prescribe sampling plans for quality control (e.g., AQL for pinholes).
• Sample Size for Chemotherapy Permeation: Not explicitly stated. ASTM D6978-05, the standard referenced, outlines the methodology for testing permeation, which would involve multiple samples.
• Data Provenance: The testing was conducted to meet established ASTM and ISO standards. The manufacturer is ECO MEDI GLOVE SDN. BHD. based in Malaysia. The tests appear to be prospective for the purpose of demonstrating substantial equivalence.

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

• N/A: This is a physical device, and its performance is measured against objective standards (ASTM, ISO) and laboratory tests, not subjective expert judgment for ground truth establishment.

4. Adjudication method for the test set:

• N/A: Not applicable for objective physical and chemical testing.

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:

• N/A: This is not an AI/ML device, and no MRMC study was performed.

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

• N/A: This is not an AI/ML device. The "standalone" performance refers to the glove's physical and chemical properties.

7. The type of ground truth used:

• Objective Standards and Laboratory Measurements: The "ground truth" for this device is based on its ability to meet the specifications outlined in recognized international standards (ASTM D6319-10 for nitrile gloves, ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151-06 for pinholes, ASTM D6124-06 for residual powder, and ISO 10993-10 for biocompatibility). These are quantifiable, objective measurements.

8. The sample size for the training set:

• N/A: There is no "training set" as this is not an AI/ML device.

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

• N/A: There is no "training set" for this type of device.

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A powder-free patient eaxmination 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 for use with chemotherapy drugs.In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.

The Blue Nitrile Medical Examination Gloves ,Powder Free, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).

The provided text describes the acceptance criteria and performance of EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (K161187). This device is a patient examination glove and is assessed against the ASTM D6319-10 standard for Nitrile Examination Gloves and ASTM D6978-05 for permeation by chemotherapy drugs.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The core test for this device, beyond general glove properties, is its resistance to chemotherapy drugs. The acceptance criteria are implicit in the performance shown for the predicate device (K141982) and the subject device's indication to be "tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05 standards." The performance is reported as the "Minimum Breakthrough Detection Time (Min) in µg/cm²/minute." A longer breakthrough time indicates better resistance.

Note: The document explicitly states for the subject device: "The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time: Carmustine (BCNU) (3.3mg/ml) - Minimum Breakthrough detection time 1.3 μg/cm²/minute. Thiotepa (10mg/ml) - Minimum Breakthrough detection time 67.8 μg/cm²/minute." This highlights that even with lower breakthrough times for these specific drugs, if tested according to the standard, the device is considered to meet the "tested for use with chemotherapy drugs" indication. The predicate device also showed similar, and in one case even lower (Thiotepa, 2 minutes), breakthrough times for these aggressive drugs.

Beyond chemotherapy drug resistance, the document also details other specifications that the gloves meet, primarily referencing ASTM D6319-10 (Standard specification for Nitrile Examination Gloves):

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

The document does not explicitly state the sample sizes for the various tests (e.g., how many gloves were tested for chemotherapy permeation, physical properties, or biocompatibility). However, it consistently refers to compliance with established ASTM standards (D6319-10, D6978-05, D5151-06, D6124-06). These standards inherently define the sampling plans and testing methodologies.

• Data Provenance: The studies were performed by the manufacturer, Eco Medi Glove Sdn. Bhd., located in Malaysia. The type of study would be considered prospective testing in a laboratory setting to evaluate the device's performance against defined standards.

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

This is a performance test for a physical medical device (gloves) against established engineering and material science standards (ASTM). It does not involve "ground truth" derived from expert medical opinion in the way an AI diagnostic algorithm would.

Instead, the "ground truth" (or more accurately, the pass/fail criteria) is established by the ASTM standards themselves, which are developed by experts in materials science, engineering, and medical device manufacturing. The testing would be performed by qualified laboratory technicians and engineers who are proficient in executing these standardized tests. The report does not specify the number or qualifications of these individuals directly, as their adherence to the standard methodologies is sufficient.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a direct performance test against quantitative standards, not an assessment requiring expert adjudication of a qualitative outcome. The outcomes are objective measurements (e.g., breakthrough time, tensile strength, elongation, presence of pinholes) or standardized biological evaluations (irritation, sensitization).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on their performance. This product is a physical medical device (examination gloves).

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

Yes, in a sense, a standalone performance assessment was done. The glove's performance (e.g., resistance to chemotherapy drugs, physical properties, biocompatibility) was assessed independently of human interaction during its use. The "algorithm" here is the physical glove itself and its material properties, and its performance was measured directly.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these gloves is based on established standard specifications and test methods.

• For physical properties and general requirements for nitrile examination gloves, the ground truth is defined by ASTM D6319-10.
• For resistance to chemotherapy drug permeation, the ground truth and test methodology are defined by ASTM D6978-05.
• For pinholes, ASTM D5151-06.
• For residual powder, ASTM D6124-06.
• For biocompatibility, the tests (Primary Skin Irritation, Dermal Sensitization) follow recognized biological evaluation standards (often ISO 10993 series, though not explicitly stated for these specific tests, but generally implied for such evaluations).

These are all objective, quantitatively measurable criteria as defined by consensus standards, not subjective expert consensus, pathology, or outcomes data in the medical sense.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm or a diagnostic tool that requires a "training set" in the context of machine learning. The "training" in manufacturing comes from process control, material selection, and quality systems, not data-driven model training.

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

Not applicable, for the same reasons as in point 8.

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A powder-free 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. It is for over-the-counter use.

Pink Nitrile Examination Glove. Powder Free. as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Pink color, Powder free and non sterile.

This document is a 510(k) Pre-market Notification for a medical device: "EMG Pink Nitrile Examination Glove Powder Free." The primary goal of the submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K141590, EMG Blue Nitrile Medical Examination Glove Powder Free).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

• The document does not explicitly state the sample sizes for the tests conducted to demonstrate compliance with ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, or the biological evaluation tests (skin irritation and dermal sensitization). These standards specify sampling plans, but the specific number of units tested is not reported in this summary.
• Data Provenance: The submitting company, ECO MEDI GLOVE SDN. BHD., is located in Malaysia. Therefore, the data likely originates from testing conducted there, or by third-party labs often contracted by manufacturers for such compliance testing. The document states a "Preparation Date" of 20th July 2016, indicating the tests were conducted prior to this date. The data is retrospective relative to the submission date.

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

• This information is not provided in the document. The tests performed (e.g., physical properties, pinhole, residual powder, biological evaluation) are standardized laboratory tests. The "ground truth" for these tests is defined by the methodology of the ASTM standards and biological evaluation protocols themselves, rather than by expert consensus on interpretations of images or findings. While qualified laboratory personnel perform these tests, their specific "expert" qualifications (e.g., years of experience) or number are not detailed.

4. Adjudication method for the test set:

• Not applicable as the tests are objective, standardized laboratory measurements and assessments according to specific ASTM standards (D6319-10, D5151-06, D6124-06) and biological evaluation protocols. These types of tests typically do not involve multiple expert readers and subsequent adjudication in the way medical imaging interpretation might.

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. This document pertains to the 510(k) clearance of a patient examination glove, which is a physical medical device. It does not involve AI software or human readers interpreting medical cases. No MRMC study was performed.

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

• Not applicable. This is a physical medical device (glove), not an algorithm or AI software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

• The "ground truth" is established by adherence to recognized international and national standards for examination gloves:
  • ASTM D 6319-10: Standard Specification for Nitrile Examination Gloves for Quality Assurance, Dimensional, and Physical Property (Tensile Strength, Ultimate Elongation) testing.
  • ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves for Pin-hole Level.
  • ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves for Residual Powder.
  • Biological Evaluation on Medical Device - Primary Skin Irritation Test: Assesses skin irritation potential.
  • Biological Evaluation on Medical Device - Dermal Sensitization Assay: Assesses the potential for allergic sensitization.
• These standards and biological tests define the objective criteria and methodologies against which the device's performance is measured.

8. The sample size for the training set:

• Not applicable. This product is a physical device, not an AI/ML algorithm that requires a training set. The data presented are for performance testing of the final product.

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

• Not applicable, as there is no training set for this device.

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

Blue Nitrile Examination gloves powder free with Peppermint Scented , non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Blue color, Powder free and non sterile.

The provided document is an FDA 510(k) Premarket Notification for a medical device: "EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented." This document focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving superiority or conducting complex clinical studies for a novel AI/software device.

Therefore, the specific information requested about acceptance criteria for AI/software, multi-reader studies, ground truth establishment for training sets, etc., as typically applied to AI/ML medical devices, is not applicable to this submission for examination gloves.

However, I can extract and present the acceptance criteria and performance data for the examination gloves as presented in the document, which are primarily based on physical properties and biocompatibility testing against established ASTM standards.

Here's the information derived from the document, tailored to the context of examination gloves:

Acceptance Criteria and Device Performance for EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented

The device is an examination glove, and its performance is evaluated against established industry standards (primarily ASTM D6319-10 for Nitrile Examination Gloves and ISO 10993-10 for biocompatibility) and compared to a predicate device. The goal of this 510(k) submission is to demonstrate "substantial equivalence" rather than a superior clinical outcome delivered by an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The following table summarizes the key performance characteristics and their corresponding acceptance criteria, along with the reported performance of the EMG Powder Free Nitrile Examination Glove. The predicate device's performance is also included for comparative purposes, as the entire submission is based on demonstrating equivalence.

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

The document does not explicitly state the exact sample sizes (e.g., number of gloves) for each specific physical and biocompatibility test performed. However, it indicates adherence to ASTM standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6124-06) and ISO 10993-10. These standards specify sampling plans and test methodologies.

• Data Provenance: The tests would have been performed on samples of the manufactured EMG Powder Free Nitrile Examination Glove. The manufacturer, Eco Medi Glove Sdn. Bhd., is based in Malaysia. The testing described is retrospective in the sense that it's performed on finished product samples to demonstrate compliance with standards for market clearance, rather than a clinical trial on patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of device submission. Examination gloves are physical products evaluated against standardized engineering and biological performance tests, not against interpretations of medical images or other data where expert consensus is needed to establish "ground truth." The "ground truth" is the objective measurement of physical properties (e.g., tensile strength, dimensions, pinholes) and biological responses (e.g., irritation, sensitization) following well-defined test protocols.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often for medical imaging, to resolve disagreements among reviewers. The testing for examination gloves is based on objective, quantifiable measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where the impact of the AI on human reader performance is evaluated. For examination gloves, the safety and effectiveness are tied to their physical properties and biocompatibility, not to how they might assist human interpretation of data.

6. If a Standalone (Algorithm Only) Performance Study was Done

No, a standalone performance study (algorithm only) was not done. This submission is for a physical medical device (examination gloves), not an artificial intelligence algorithm.

7. The Type of Ground Truth Used

The "ground truth" for examination gloves is established through adherence to recognized industry standards and laboratory testing protocols. This includes:

• Engineering/Physical Standards: ASTM D6319-10 for physical characteristics (dimensions, tensile strength, elongation), ASTM D5151-06 for pinhole levels, and ASTM D6124-06 for residual powder.
• Biocompatibility Standards: ISO 10993-10 for primary skin irritation and dermal sensitization.

The "ground truth" is the objective measurement result from these standardized tests, which is then compared against the predetermined acceptance criteria within the standards.

8. The Sample Size for the Training Set

This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The product is manufactured and then tested to ensure it meets pre-defined specifications.

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

This concept is not applicable as there is no "training set" for this physical device.

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