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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.

This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, physical properties, pinholes). However, the tests are based on recognized standards (ASTM, ISO), which typically specify sample sizes or sampling plans (e.g., AQL levels).

• Data Provenance: The studies are non-clinical (laboratory/bench testing, and animal studies for biocompatibility). The document does not specify the country of origin of the test data but implies it was conducted by or for the manufacturer. All tests are retrospective, meaning they were performed on already manufactured product or materials to demonstrate compliance with standards.

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

This is not applicable to this type of device and study. The "ground truth" for non-clinical performance and biocompatibility relies on objective measurements according to standardized test methods, not expert consensus or clinical interpretation.

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

Not applicable. This is not a study involving human subjective assessment where adjudication would be necessary. 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. This device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI assistance are irrelevant.

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

Not applicable. This device is a medical glove and does not involve an algorithm.

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

The "ground truth" for the performance of these gloves is defined by the acceptance criteria specified in internationally recognized standards (ASTM and ISO). These standards establish objective parameters and methods for evaluating physical properties (dimensions, tensile strength, elongation), integrity (pinholes), material properties (powder residual), and biological safety (biocompatibility).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no concept of a "training set."

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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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided text details the 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description of an AI-powered device. Therefore, much of the requested information regarding AI device studies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) is not applicable or present in this document.

However, I can extract the acceptance criteria and reported device performance for these medical gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The device's compliance with the acceptance criteria is demonstrated through non-clinical performance tests that support a determination of substantial equivalence. The document explicitly states:

• "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet per requirements per ASTM D5250-06 (Reapproved 2011)、 ASTM CFR 800.20 10993-10: D6124-06(Reapproved 2011), per 21 and ISO 2002/Amd. 1 :2006."
• "The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above."

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

• The document does not specify sample sizes for the tests performed (e.g., number of gloves tested for dimensions, pinholes, etc.).
• Data provenance: Not explicitly stated, but given the submitter's address is in China, it's highly probable the testing was conducted in China or by a contracted lab. The tests are based on recognized international (ISO) and US (ASTM, CFR) standards.

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

• Not applicable. This is a medical glove, not an AI device requiring expert ground truth for interpretation. The "ground truth" here is adherence to specified physical and chemical properties as per standards.

4. Adjudication method for the test set:

• Not applicable. This is a medical glove, not an AI device requiring adjudication of interpretations. Compliance is determined by objective measurements against established standard thresholds.

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 medical glove, not an AI device.

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

• Not applicable. This is a medical glove, not an AI device.

7. The type of ground truth used:

• The "ground truth" for the performance of these medical gloves is based on established industry measurement standards and specifications (e.g., ASTM D5250-06, 21 CFR 800.20, ISO 10993-10:2002). These standards define acceptable ranges for physical properties, chemical residue, and biocompatibility.

8. The sample size for the training set:

• Not applicable. This is a medical glove, not an AI device requiring a training set.

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

• Not applicable. This is a medical glove, not an AI device requiring a training set.

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Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material .intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided document describes the acceptance criteria and performance of "Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Hongxin Plastic Products Co.,Ltd. It's important to note that this is a medical device (gloves), not an AI algorithm, so many of the questions related to AI studies (like MRMC studies, training sets, expert ground truth for imaging, etc.) are not applicable.

Here's the information extracted and formatted according to your request:

Acceptance Criteria and 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 does not specify a "test set" in the context of an algorithmic evaluation. The performance criteria are based on standardized tests for medical gloves. Sample sizes for these tests are typically defined within the respective ASTM and ISO standards (e.g., number of gloves tested for pinholes, number of rabbits for irritation tests). The document does not provide these specific sample sizes.

Data Provenance: The tests were conducted by the manufacturer to demonstrate compliance with the specified standards. The country of origin of the data is not explicitly stated beyond the manufacturer being in China. The data would be considered prospective as it's generated through testing the manufactured product according to established protocols.

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 as the device is a physical medical product (gloves) and not an AI algorithm requiring expert adjudication for ground truth. The "ground truth" here is determined by objective measurements and tests against established physical and biological standards. For biocompatibility tests (like skin irritation), qualified laboratory personnel would conduct and interpret the results to determine "passes" or "fails" against defined criteria, but these are not "experts establishing ground truth" in the sense of medical image interpretation.

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

Not applicable for a physical medical device. Performance is determined by test results against predefined criteria in the 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

Not applicable. This is not an AI-powered diagnostic or assistive device.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device is based on objective measurements and laboratory tests defined by:

• ASTM standards: For dimensions, physical properties, and powder residue.
• 21 CFR 800.20: For freedom from pinholes.
• ISO 10993-10: For biocompatibility (primary skin irritation and dermal sensitization).

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

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