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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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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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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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