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Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device is a powder free vinyl patient examination glove, provided as non-sterile and disposable device. It is provided with clear color. Available in four sizes small, medium, large, and extra - large users can choose the most suitable option.

The provided FDA 510(k) clearance letter and summary describe the regulatory approval process for "Powder-Free Vinyl Exam Gloves, clear." This is a Class I medical device, and the clearance is based on demonstrating substantial equivalence to a predicate device, K220469, "Disposable Vinyl Examination Glove."

The study described is not a clinical study involving human patients or complex AI algorithms necessitating multi-reader, multi-case (MRMC) studies or expert adjudication of medical images. Instead, it's a non-clinical performance study focused on the physical, chemical, and biological properties of the gloves.

Therefore, many of the requested points related to AI performance, human reader improvement, and complex ground truth establishment for medical diagnosis are not applicable to this type of device and study.

Here's the breakdown of the information that is applicable:

Acceptance Criteria and Device Performance for Powder-Free Vinyl Exam Gloves, Clear

The acceptance criteria and device performance are primarily based on non-clinical testing according to recognized industry standards (ASTM and ISO). The goal is to demonstrate that the subject device meets the same performance specifications as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a precise numerical sample size (e.g., number of gloves) for each non-clinical test. However, it indicates that testing was performed according to the specified ASTM and ISO standards, which inherently define the necessary sample sizes and methodologies for ensuring statistical validity within their respective contexts (e.g., AQL for the water leak test).
• Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Basic Medical Technology Inc." is located in Ontario, CA (presumably California, USA) and the predicate device manufacturer is a Chinese company (CHIFENG HUAWEI MEDICAL SCIENCE TECHNOLOGY CO., LTD.), the testing could have been performed either in the US, China, or accredited labs elsewhere.
• Retrospective or Prospective: This testing is inherently prospective as it involves the manufacturing and testing of new device samples to demonstrate compliance with standards.

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

• Not Applicable: For this type of non-clinical device (medical gloves), "ground truth" is not established by medical experts interpreting images or clinical data. Instead, it's established by the physical and chemical properties of the material as measured by standardized laboratory methods. The "experts" would be the accredited laboratory personnel performing the tests according to the ASTM and ISO standards, not medical professionals like radiologists.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of complex data (like medical images). This is a physical product testing scenario where results are quantitative measurements against objective criteria, so no adjudication by multiple human observers is required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable: An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in tasks like diagnostic imaging. This device is a pair of medical gloves; there is no AI component or human reader interpretation task involved.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not Applicable: This pertains to AI algorithm performance evaluation. There is no AI algorithm in "Powder-Free Vinyl Exam Gloves, clear." The "standalone" performance here refers to the device's physical and biological properties.

7. Type of Ground Truth Used

• The "ground truth" for this device is based on objective, standardized measurements of its physical properties (e.g., dimensions, tensile strength, elongation, hole detection) and biological compatibility (e.g., cytotoxicity, irritation, sensitization), as defined by internationally recognized ASTM and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

• Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm. The manufacturing process of the gloves would have its own quality control and process validation, which might involve data collection analogous to a training set for process refinement, but this is distinct from AI model training.

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

• Not Applicable: As there is no AI training set, this question is irrelevant.

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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.

Disposable Powder Free Vinyl Exam Glove, Blue Color

I am sorry, but the provided document does not contain the information requested regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Disposable Powder Free Vinyl Exam Glove, Blue Color". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or expert qualifications.

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

POWDER-FREE VINYL EXAM GLOVES

This document is a 510(k) premarket notification decision letter from the FDA for "POWDER-FREE VINYL EXAM GLOVES." It is not a study report or technical documentation that describes acceptance criteria for an AI/ML medical device. Therefore, I cannot extract the requested information.

The document confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not contain any details about performance testing, sample sizes, expert review, or ground truth establishment relevant to AI/ML device evaluation.

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A Powder-free Vinyl Patient Examination Glove is disposable device made of PVC material that coated with PU coating to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials individual contaminants.

The Powder-free vinyl exam glove is a disposable Class 1 medical device made from PVC material and is intended to be worn on the hands of health care personnel for medical purpose to provide a barrier against potentially infectious materials and other contaminants.

The provided documentation pertains to a 510(k) premarket notification for "Powder-Free Vinyl Exam Gloves" by SHANGHAI LANFAN CO., LTD. This document does not describe a study involving a device that analyzes data or provides diagnostic information. Instead, it concerns a Class I medical device (gloves) and demonstrates its substantial equivalence to predicate devices based on physical properties and biocompatibility. Therefore, most of the requested information regarding acceptance criteria and studies for device performance (especially for AI/software devices) is not applicable.

However, I can extract the relevant information regarding the glove's "acceptance criteria" through performance attributes and the testing conducted to meet those criteria.

1. A table of acceptance criteria and the reported device performance

For medical gloves, acceptance criteria typically relate to physical properties and barrier integrity. The document states that the device meets the "current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves." While the specific values from ASTM D5250-06 are not detailed in this summary, the general categories of assessment are inferred.

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

The document does not specify the exact sample sizes used for testing according to ASTM D5250-06. Such standards typically define sampling plans. The data provenance is China, as the submitter, SHANGHAI LANFAN CO., LTD, is located in Shanghai, China. The testing appears to be "retrospective" in the sense that it's standard quality control and product validation testing rather than a prospective clinical trial.

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. This device is a glove, and its performance is assessed via objective physical and chemical tests, not by expert interpretation of data.

4. Adjudication method for the test set

This question is not applicable as the performance is evaluated through objective measurements against established standards, not via expert 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

This question is not applicable as the device is a medical glove, not an AI or diagnostic imaging device.

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 medical glove.

7. The type of ground truth used

For physical and chemical properties:

• Standard Specifications: ASTM D5250-06 "Standard Specification for Polyvinyl Examination Gloves for Medical Application" serves as the ground truth for acceptable performance limits and test methods for physical characteristics.
• Biocompatibility Testing Standards: Standards for Primary Skin Irritation (rabbit) and Delayed Contact Sensitization (guinea pig) serve as the ground truth for biocompatibility.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a medical glove. The product is manufactured and tested according to specified standards.

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

This question is not applicable.

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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.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.

The provided text describes a 510(k) submission for "Shanghai Antares Industries Inc. Disposable Powder Free Vinyl Synthetic Exam Gloves, With Vitamin Complex, Nopal and Lanolin (Blue Color)". Medical gloves are Class I devices and generally demonstrate substantial equivalence through performance testing against recognized standards.

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

1. A table of acceptance criteria and the reported device performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific sample size is not explicitly stated but is implicitly defined by the ASTM D5250-00E4 standard and the AQL.
• Watertight Integrity: Inspection level I, AQL 2.5. The specific sample size is not explicitly stated but is implicitly defined by the ASTM D-5151-99 standard and the AQL.
• Powder-Free Claim: Not explicitly stated, but the test (ASTM D6124-01) is conducted at "finished inspection".
• Primary Skin Irritation and Skin Sensitization: Sample size for these biocompatibility tests is not explicitly mentioned.

The data provenance is prospective manufacturing testing of the Shanghai Antares Industries Inc. gloves. The country of origin of the data is implicitly China, where the manufacturer (Shanghai Antares Industries Inc.) is located.

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 same way an imaging AI algorithm would. The "ground truth" is established by the objective measurement against the specified ASTM standards and FDA test methods. Therefore, the concept of "number of experts" or their "qualifications" for ground truth establishment is not applicable here.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established standards, not subjective interpretations 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 is a medical device (examination gloves), not an AI algorithm for diagnosis or interpretation that would typically require an MRMC study comparing human performance with and without AI.

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

Not applicable. This is a physical medical device.

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

The ground truth for this device is based on objective performance standards and test methodologies established by ASTM (American Society for Testing and Materials) and FDA. For example:

• Physical properties (dimensions, tensile strength) are objectively measured against limits defined in ASTM D5250-00E4.
• Watertight integrity (pinhole) is objectively measured against the criteria in ASTM D-5151-99.
• Powder content is objectively measured against the limit of 2 mg per glove using ASTM D6124-01.
• Biocompatibility (skin irritation and sensitization) results are based on standardized biological testing protocols.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense. The "training" would be analogous to the manufacturing process adhering to quality controls.

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

Not applicable. As explained above, there is no "training set" for a physical device in the context of an AI algorithm. The manufacturing process is designed to produce gloves that inherently meet the established performance standards.

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

Not Found

The requested information is not available in the provided text. The document is a 510(k) substantial equivalence letter from the FDA for "Powder-Free Vinyl Exam Gloves." It does not contain details about specific acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a legally marketed predicate device based on its intended use.

The document discusses regulatory information, labeling requirements, and contact information, but not performance study data of the type requested.

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A PATIENT EXAMINATION GLOVE 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.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES

I'm sorry, but your query cannot be fulfilled. The document provided is an FDA 510(k) clearance letter for a medical device (Disposable Powder Free Vinyl Synthetic Exam Gloves). It confirms that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain any information about the acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be necessary to answer your specific questions. These details are typically found in the actual 510(k) submission, not in the clearance letter itself.

Therefore, I cannot extract the requested information from the provided text.

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A PATIENT EXAMINATION GLOVE 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.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is an FDA 510(k) clearance letter for "Disposable Powder Free Vinyl Exam Gloves," dated August 14, 2003.

This type of document primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to a legally marketed predicate device. It certifies that the device can proceed to market under general controls.

The letter does not contain:

• Specific acceptance criteria (such as performance metrics like tensile strength, elongation, or barrier integrity). While such criteria would have been part of the manufacturer's submission, they are not detailed in this clearance letter.
• Details of the study or tests performed by Symertex Company Limited to demonstrate compliance with performance standards. The FDA's review in a 510(k) typically relies on the manufacturer's data demonstrating that their device meets recognized standards or is substantially equivalent to a predicate.
• Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies. These are typically associated with more complex medical devices that involve diagnostic or therapeutic algorithms, not examination gloves.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement clearly indicates the basis for clearance is substantial equivalence to a predicate, not necessarily detailed performance study results within this letter itself.

Therefore, I cannot extract the requested information from the provided text.

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A PATIENT EXAMINATION GLOVE 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.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES

{"text": "The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Examination Gloves." This document primarily addresses the regulatory approval of a medical device and its intended use. It does not contain information about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in technical reports for AI/device performance. \n\nTherefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document is a regulatory approval letter, not a device performance study report."}

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A PATIENT EXAMINATION GLOVE 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.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Examination Gloves With Vitamin E". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not describe acceptance criteria for a study, nor does it present the results of a study to prove a device meets acceptance criteria. The structure of the request, with questions about sample size, expert ground truth, adjudication methods, and AI performance, is typically relevant for studies evaluating the performance of AI/ML-driven medical devices or diagnostic tests.

This letter solely concerns the regulatory clearance of a physical medical device (examination gloves), not an AI/ML algorithm or a diagnostic test with performance metrics of the type requested. Therefore, none of the specific questions can be answered from the provided text.

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