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A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.

The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand.

The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo 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 gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).

This document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves. The "device" in question is medical examination gloves, not an AI/ML powered medical device, therefore many of the requested criteria (e.g., number of experts, MRMC studies, training/test set ground truth establishment) are not applicable.

However, I can extract information related to acceptance criteria and performance as presented in the document for the glove device.

Here's the relevant information based on the provided document:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions sample sizes indirectly through "Inspection Level G-1" and "AQL 2.5" which are statistical sampling plans. For instance, for freedom from holes, it states: "XS/XXL – 0/160; S/M/XL – 1/250; L – 2/250", which implies a sample size of 160 or 250 units depending on the glove size, with an allowable number of non-conforming units (holes) of 0, 1, or 2.

The data provenance is not explicitly stated as "country of origin of the data" or "retrospective/prospective." However, the submitter's address is "PT. MAJA AGUNG LATEXINDO Jl. Utama No. 98, Pujimulyo, Sunggal 20352 Deli Serdang North Sumatera - Indonesia," suggesting the testing was conducted in Indonesia or by a lab associated with the manufacturer. The testing methods refer to ASTM standards, which are internationally recognized. This is pre-market testing, so it's inherently prospective data for the regulatory 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):

Not applicable. This device is a physical product (medical gloves) and not an AI/ML medical device. "Ground truth" in this context refers to measurements against established physical and chemical standards, not expert interpretations of medical images or data.

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

Not applicable. This is not an image-based or clinical data-based study requiring adjudication. The results are objective measurements from laboratory tests.

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. No AI/ML component in this medical device.

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

Not applicable. No algorithm component in this medical device.

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

The "ground truth" for this device is based on established, objective, and quantifiable performance criteria defined by recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for medical gloves. This includes:

• Physical dimensions
• Physical properties (tensile strength, elongation)
• Freedom from pinholes (measured by water leak test)
• Residual powder content
• Permeation resistance to specific chemicals (measured as breakthrough time)
• Biocompatibility (in vitro/in vivo tests for irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set:

Not applicable. No training set is used as this is not an AI/ML device. The testing described pertains to product validation and verification against established performance standards.

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

Not applicable. No training set is used. The "ground truth" for the performance metrics is established by the test methods outlined in the aforementioned ASTM and ISO standards. These standards prescribe the procedures and criteria for evaluating the glove's performance.

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The Powder Free Nitrile Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The proposed device is a Powder Free Nitrile Examination Glove. The glove is available in one color: Black. The proposed device is non-sterile. The Powder Free Nitrile Examination Gloves, Black meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.

The document discusses the substantial equivalence of "Powder Free Nitrile Examination Gloves, Black" (K161099) to a legally marketed predicate device. The study described focuses on non-clinical performance data to demonstrate that the device meets established acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a specific "test set" sample size in terms of number of gloves tested for each characteristic. However, the data represents non-clinical performance evaluations against established standards like ASTM and ISO. The provenance of the data would be internal testing conducted by the manufacturer, PT. Maja Agung Latexindo, which is located in North Sumatera, Indonesia. The study is retrospective in the sense that the test results are presented as already completed data to demonstrate compliance.

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

This information is not provided in the document. The ground truth for the performance of the gloves is established by adherence to recognized international standards (ASTM and ISO), which detail testing methodologies and acceptance criteria. The tests themselves are standardized procedures, so the "experts" would be the technicians or engineers conducting these tests in a laboratory setting, ensuring the methods are followed correctly.

4. Adjudication Method for the Test Set:

This is not applicable as the study involves standardized physical and chemical tests rather than expert review or adjudication of subjective interpretations. The outcomes are objective measurements against predefined limits.

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 diagnostic devices that involve human interpretation of medical images or data, which is not the case for examination gloves.

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

No, this question is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for determining the device's performance is objective measurements derived from established international standards (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10:2010). These standards define the acceptable range for various physical, chemical, and biological properties of examination gloves.

8. The Sample Size for the Training Set:

This question is not applicable. The device is not an AI or machine learning model that requires a training set. The "training" here refers to the manufacturing process and quality control measures to ensure consistent product attributes.

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

This question is not applicable for the reasons stated above. The "ground truth" for the manufacturing process is established by internal quality control procedures and adherence to the specifications outlined in the referenced standards.

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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.

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.

Here's a breakdown of the acceptance criteria and study information for the "Powderfree Latex Examination Gloves" described in the provided documents:

The documents provided are a 510(k) Summary and an FDA substantially equivalent letter for "Powderfree Latex Examination Gloves" manufactured by PT. Maja Agung Latexindo. This type of regulatory filing demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.

Therefore, the study design and "acceptance criteria" here refer to meeting established industry standards for similar devices and demonstrating equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided documents. For physical property testing of gloves adhering to ASTM standards, specific sample sizes are typically defined within the ASTM standard (e.g., ASTM D3578-05ae2 for latex examination gloves specifies sampling plans for various tests like dimensions, physical properties, and watertightness).
• Data Provenance: The manufacturing location is "Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA". The testing data would originate from the manufacturer's quality control or third-party testing facilities related to their manufacturing process. The data is retrospective, as it refers to tests conducted on manufactured batches to ensure compliance with the standard.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance specifications of these gloves is defined by the ASTM D 3578-05ae2 Standard and FDA's pinhole requirements. These are engineering and performance specifications, not subjective expert interpretations of medical images or outcomes. The "experts" involved would be the engineers and quality control personnel who conducted the tests and verified compliance with the standard.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted for glove performance (tensile strength, elongation, dimensions, pinhole) are objective measurements against a defined standard.

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 not a study involving human readers or AI assistance. It is a device 510(k) submission for examination gloves, which are physical medical devices, not diagnostic software.

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

• Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• The ground truth used is established industry standards and regulatory requirements, specifically:
  • ASTM D 3578-05ae2 Standard for Powder-Free Latex Examination Gloves
  • FDA pinhole requirement for examination gloves.
  • The specifications defined in the 510(k) summary for dimensions and physical properties, which are derived from or meet these standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device manufacturing and regulatory submission. The gloves are manufactured and tested against predefined specifications.

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

• Not applicable, as there is no training set for this type of device. The specifications for performance (ground truth) were established over time through industry consensus and regulatory guidance, leading to standards like ASTM D 3578-05ae2.

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A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder free Latex Examination Gloves, BLACK

The document provided describes a 510(k) premarket notification for "Powder Free Latex Examination Gloves, Black" and outlines the technological characteristics and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Performance data is the same as mentioned immediately above," implying the reported device performance met or exceeded the specified criteria in ASTM D 3578-05ae2.

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

The document does not explicitly state the specific sample sizes used for testing each characteristic. However, it references compliance with ASTM D 3578-05ae2 Standard, which would dictate the appropriate sampling plans for each test.

The data provenance is from PT. Maja Agung Latexindo, an Indonesian manufacturer. The study appears to be retrospective in the sense that the results are presented as having already been achieved and verified against established standards.

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

The document does not provide information about the number or qualifications of experts used to establish a "ground truth" for the test set. For medical devices like examination gloves, compliance with established industry standards (like ASTM D 3578-05ae2) and regulatory requirements (like FDA pinhole requirements) serves as the primary benchmark. These standards are developed by expert consensus within their respective fields, but individual expert adjudication of specific test results for this 510(k) submission is not described.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1, none) for the test set is mentioned. Compliance is demonstrated by meeting the quantitative specifications of the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging or interpretative tasks where human readers' performance is augmented by AI. For examination gloves, the performance is mechanically and physically evaluated against defined specifications, not through human interpretation.

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

This is not applicable as the device is a physical medical glove, not an algorithm or an AI-powered system. The "performance" refers to the physical and mechanical properties of the glove itself.

7. The Type of Ground Truth Used

The ground truth used is primarily compliance with established industry standards and regulatory requirements, specifically:

• ASTM D 3578-05ae2 Standard: This standard defines the physical and performance requirements for medical examination gloves.
• FDA pin hole requirement: A specific regulatory requirement for glove integrity.
• Labeling claim: Verification that the product's actual performance aligns with its stated labeling.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (latex examination gloves), not an AI algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for a physical device like a glove.

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Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Latex Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a consolidated sample size for a single "test set" in the context of a clinical trial or algorithm evaluation. Instead, it refers to differing sample sizes/inspection levels (e.g., N=5 for Powder Free Residue, N=3 for Protein Content, N=2 for Powder Amount, Inspection Level 1 for holes) for various performance requirements.

The data provenance is presented as internal testing and conformity to standards. The document is from Indonesia, suggesting the testing was likely conducted in Indonesia. The data is retrospective in the sense that the results are presented as already achieved and certified.

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

Not applicable for this type of device and study. The "ground truth" for gloves is adherence to specified physical and chemical properties and performance standards (like ASTM D 3578-01). This is determined by laboratory testing against objective criteria, not by expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Laboratory tests against established standards do not typically involve adjudication methods like those used in clinical image interpretation. Results are quantitatively measured and compared against defined thresholds.

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 diagnostic devices that involve human interpretation of images or data, often with AI assistance. For examination gloves, the performance is assessed through laboratory testing of material properties and barrier integrity.

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

No, a standalone algorithm performance study was not done. This device is a physical product (examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on:

• Standard Specifications: Specifically, the ASTM D 3578-01 standard for latex examination gloves, which defines dimensions, physical properties (tensile strength, elongation), and barrier integrity.
• Regulatory Requirements: FDA pinhole requirements and sterility assurance levels.
• Labeling Claims: The manufacturer's specific claim of "50ug or less" for protein content.

These are all objective, quantifiable metrics determined by laboratory testing.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML model that requires a training set. The term "training set" is not relevant here.

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

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

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A latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners
A sterile latex powderfree examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.

Latex Powder free Sterile Examination Gloves

The provided text describes the acceptance criteria and a study for "Latex Powder free Sterile Examination Gloves."

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Performance data is the same as mentioned immediately above," referring to the table of "Technological characteristic of the gloves" and "Performance requirement." The "Non-clinical data" section then certifies that these requirements are met.

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

The document does not explicitly state the sample sizes for each test set. However, it does provide Inspection Levels and AQL values for some characteristics, which would imply specific sample sizes based on sampling plans. For instance:

• Freedom from holes: Inspection Level 1, AQL 2.5
• Dimensions & Thickness: Inspection Level S-2, AQL 4
• Physical Properties (after ageing): Inspection Level S-2, AQL 4
• Powder Free Residue: N=5
• Protein Content: N=3
• Powder Amount: N=2

The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer PT. Maja Agung Latexindo in North Sumatra, Indonesia. The study appears to be retrospective as it presents data for a device seeking 510(k) clearance based on established standards.

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

This information is not provided in the document. The acceptance criteria are based on ASTM standards (ASTM D 3578-01), FDA pinhole requirements, and generally accepted sterility assurance levels. The compliance is certified by the manufacturer. There is no mention of external experts establishing ground truth for individual test cases.

4. Adjudication Method for the Test Set

This information is not provided. The compliance is self-certified by the manufacturer against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is a physical product (latex gloves), not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

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

This is not applicable. The device is a physical product (latex gloves), not an AI diagnostic tool.

7. The Type of Ground Truth Used

The ground truth is based on established industry standards and regulatory requirements, specifically:

• ASTM D 3578-01 Standard (for dimensions, physical properties)
• FDA pinhole requirement
• Sterility assurance level
• Labeling claims (for powder free, powder amount)

These standards define the objective measures for performance.

8. The Sample Size for the Training Set

This is not applicable as the document describes the testing of a physical product, not the development of a machine learning algorithm that requires a training set.

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

This is not applicable as there is no training set mentioned for this product.

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