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The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Powdered Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

This document describes the acceptance criteria and performance of the NitriTech® Non-Sterile Powdered Nitrile Examination Glove, as presented in the 510(k) summary K093516. It details the tests conducted to demonstrate substantial equivalence to a predicate device and adherence to relevant ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria and Performance:

• For the "Length" and "Palm Width" tests, the reported performance is a range or a minimum value, which falls within or exceeds the specified ASTM criteria.
• For "Thickness (Finger)", the reported minimum performance (0.06mm) exceeds the ASTM minimum (0.05mm).
• For "Thickness (Palm)", the reported minimum performance (0.05mm) meets the ASTM minimum (0.05mm).
• For "Tensile Strength" (Before and After Aging), the reported range (18-33 Mpa) exceeds the ASTM minimum (14 Mpa).
• For "Ultimate Elongation" (Before Aging), the reported range (500-630%) meets or exceeds the ASTM minimum (500%).
• For "Ultimate Elongation" (After Aging), the reported range (500-610%) significantly exceeds the ASTM minimum (400%).
• "Powder Content" had no specific maximum stated in ASTM D6319-00a, but the device reports a maximum of 120mg/glove.
• For "Primary Skin Irritation" and "Dermal Sensitization", the reported scores are well below the thresholds indicating irritation or hypersensitivity, thus meeting the biocompatibility requirements.

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

The exact sample sizes for each specific test (e.g., number of gloves tested for holes, length, etc.) are not explicitly stated in the provided 510(k) summary. The summary refers to "Third Party test data is available in Appendix A" and "Ammendment E", which would contain these specifics.

Data Provenance: The tests were conducted by a "Third Party" and "Mediamal Testing and Consultancy Services" for biocompatibility. The country of origin of this data is not specified within the provided text. The data is retrospective in the sense that the tests were performed on finished product samples prior to the 510(k) submission.

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

This section is not applicable as the device is a physical examination glove. The "ground truth" for its performance is established through standardized physical, chemical, and biological testing methods (ASTM, CPSC, ISO standards), not through expert consensus on interpretation. Therefore, no experts in a clinical interpretation sense were used to establish ground truth for this device performance data.

4. Adjudication Method for the Test Set

This is not applicable for the type of testing performed on an examination glove. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or imaging interpretation where there is subjective assessment that requires consensus. The performance tests for the glove are objective measurements (e.g., length, thickness, tensile strength, hole detection) or standardized biological assays with clear pass/fail criteria.

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 an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This is not applicable. The device is an examination glove, not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established industry standards and objective measurements. Specifically:

• ASTM D6319-00a: Standard Specification for Nitrile Examination Gloves for Medical Application, which defines acceptable ranges and methods for physical properties (dimensions, thickness, tensile strength, elongation) and hole detection.
• ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (used for tensile properties unaged).
• ASTM D573: Standard Test Method for Rubber—Deterioration in an Air Oven (used for tensile properties aged).
• ASTM D6124-06 Section 7 Procedure II: Standard Test Method for Residual Powder on Medical Gloves.
• CPSC Title 16 Chapter II Part 1500: Regulations for the Federal Hazardous Substances Act, specifically for Primary Skin Irritation.
• ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

These standards define the pass/fail criteria and acceptable limits, serving as the objective ground truth against which the glove's performance was measured.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (examination glove) and does not involve AI or machine learning, thus no "training set" in that context was used. The manufacturing process itself (Good Manufacturing Practices, or GMPs) ensures consistency, and quality control (QC) testing of batches ensures compliance with standards.

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

This is not applicable for the same reasons as #8.

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The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Powder-Free Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves:

This document is a 510(k) summary for a medical device (examination gloves). As such, the "acceptance criteria" and "study" described are for the device itself and its physical properties and biocompatibility, not for an AI algorithm. Therefore, many of the questions related to AI-specific study design (like MRMC, standalone AI performance, training sets, expert qualifications for ground truth in AI) are not applicable.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

* Indicates data points explicitly marked with an asterisk in the source document, referencing "Third Party test data is available in Appendix A" or "Amendment F" (for biocompatibility).

Study Details (Applicable to Device Performance)

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

The document provides acceptance criteria from ASTM D6319-00a and CPSC/ISO standards. It states that the device "meets the ASTM D6319-00a Standard" and "meets... CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements."

• Test Sets: The document refers to various ASTM test methods (D5151 for holes, D412/D573 for tensile properties, D6124-06 for powder content) and specific biocompatibility tests (CPSC Title 16 Chapter II Part 1500 for Primary Skin Irritation and ISO 10993-10 for Dermal Sensitization).
• Sample Sizes: The exact sample sizes for each specific test (e.g., how many gloves were tested for holes, how many animals for biocompatibility) are not explicitly specified in this summary document. It only provides the performance results.
• Data Provenance: The document states "Third Party test data is available in Appendix A" for the general performance tests and "Third Party test data is available in Amendment F" for biocompatibility. The biocompatibility tests were completed by "Mediamal Testing and Consultancy Services." The country of origin for the data is not specified beyond originating from this third-party testing entity. The studies are prospective in nature, as they involve actively testing new device samples.

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

This question is not applicable to this type of device and study. The "ground truth" here is established by standardized physical and chemical tests (e.g., measuring glove dimensions, tensile strength, chemical content, biological reactions) rather than expert interpretation of complex data (like medical images). The "experts" would be the technicians and scientists performing the ASTM, CPSC, and ISO standardized tests, ensuring they follow the protocols correctly. Their qualifications are inherent in the accreditation of the third-party testing facility.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements or standardized biological assays, not subjective assessments requiring adjudication among multiple human readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. No AI algorithm is involved.

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

The ground truth is established by:

• Standardized Physical Measurements: Length, width, thickness, tensile strength, elongation are objective physical properties measured according to ASTM standards.
• Chemical Analysis: Powder content is determined by a chemical analysis method (ASTM D6124-06).
• Standardized Biological Assays: Primary Skin Irritation and Dermal Sensitization tests are conducted according to CPSC and ISO standards on biological models (animal testing as implied by the standards for such biocompatibility tests). The "ground truth" for irritation/sensitization is based on observing specific, quantified biological responses compared to established thresholds.

8. The sample size for the training set

Not applicable. There is no AI model or algorithm that requires a "training set" for these examination gloves. The device is evaluated based on its inherent physical and chemical properties.

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

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

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Sterile, Blue Color Powder Free Nitrile Examination Glove":

This document describes a 510(k) summary for a medical device, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. For such devices, the "acceptance criteria" are generally compliance with recognized standards and performance specifications, and the "study" is the testing conducted to show this compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test within the "Summary of Performance Data." However, for gloves, industry standards like ASTM D6319-05 typically specify sampling plans (e.g., AQL levels for attributes like watertightness). The "Multiple Normal G1" indicated for the Watertight test likely refers to a sampling plan for inspection level G1.

The data provenance is from Malaysia (BIOGREEN YIELDS SDN. BHD. is located in Sitiawan, Perak, Malaysia). The nature of the tests (physical and chemical properties, bio-compatibility) indicates this data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this submission.

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

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is established by direct measurement of physical and chemical properties and biological reactions according to standardized protocols (ASTM D6319-05, FDA watertight test, bio-compatibility tests). Therefore, there were no human experts establishing ground truth in the context of interpretation; rather, qualified laboratory personnel would have conducted the tests according to established scientific methods.

4. Adjudication method for the test set

Not applicable for this type of device testing. Adjudication is relevant for subjective interpretations, often in diagnostic imaging, where multiple experts may disagree. Here, the tests are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a physical product (gloves) and does not involve AI or human "readers" in its performance evaluation.

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

No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product and its performance is measured directly against established physical and chemical standards, not through an AI algorithm.

7. The type of ground truth used

The ground truth used is based on:

• Performance Standards/Specifications: Established by recognized standards organizations (ASTM D6319-05) and regulatory bodies (FDA 1000ml watertight test).
• Objective Measurements: Direct quantitative and qualitative measurements of physical properties (length, width, thickness, tensile strength, elongation), chemical properties (powder content, moisture content), and biological reactions (bio-compatibility tests).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning sense. The manufacturing process itself (which is subject to Good Manufacturing Practices) ensures consistency, but there's no data set used to "train" the product's performance.

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

Not applicable. As there is no training set for this physical device, there is no ground truth established for a training set.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a8 and FDA Water leak test.

The provided document describes the acceptance criteria and performance of "MULTIPLE PRIVATE LABELS, NON-STERILE, POWDER-FREE POLYURETHANE, WHITE COLOR EXAMINATION GLOVES" by YTY Industry (Manjung) Sdn Bhd.

Here's a breakdown of the requested information:

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 the specific sample sizes used for each test. It refers to the ASTM D6319-00a standard and FDA 1000ML watertight test, which would define the sampling plans. The data provenance is from Malaysia, specifically YTY Industry (Manjung) Sdn Bhd. The study appears to be prospective for the device being submitted, as it's testing the performance of their gloves against established standards.

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 acceptance criteria are based on the ASTM D6319-00a standard and FDA watertest, which are established industry and regulatory standards, not expert consensus for this specific study.

4. Adjudication Method for the Test Set:

This information is not provided. The assessment appears to be based on direct measurement and comparison against defined thresholds in the ASTM standard and FDA test, rather than an adjudication process between human reviewers.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the physical and performance characteristics of a medical glove, not on the interpretation of medical images or data by human readers with or without AI assistance.

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

This question is not applicable as the device is a physical medical glove and not an algorithm or AI system. The performance tests are direct measurements of the glove's properties

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is based on established industry standards and regulatory requirements. Specifically:

• ASTM D6319-00a: Standard Specification for Polyurethane Patient Examination Gloves.
• FDA 1000ML watertight test.
• Bio-compatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization).

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical product (medical glove), not an AI algorithm that requires a training set.

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

This question is not applicable for the same reason as point 8.

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

VINYL EXAMINATION GLOVES, POWDER-FREE

This appears to be a 510(k) clearance letter from the FDA for Vinyl Examination Gloves, Powder-Free. This type of document does not contain the information requested in your prompt regarding acceptance criteria and study details.

The provided text simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information for the applicant.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or test results.
2. Sample size used for the test set and the data provenance: No device testing details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth or expert review details are provided.
4. Adjudication method for the test set: Not applicable as no test set details are provided.
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 a medical glove, not an AI diagnostic device, so an MRMC study is not relevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
7. The type of ground truth used: No ground truth details are provided.
8. The sample size for the training set: Not applicable as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable as this is not a machine learning device.

The 510(k) process for devices like examination gloves primarily relies on demonstrating substantial equivalence to existing predicate devices, often through adherence to recognized standards (e.g., ASTM standards for glove performance). The detailed testing reports supporting this substantial equivalence are typically submitted by the manufacturer to the FDA but are not generally part of the publicly released 510(k) clearance letter itself.

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