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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 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 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.

Ask a specific question about this device

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."}

Ask a specific question about this device

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.

Ask a specific question about this device

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

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a letter from the FDA regarding a 510(k) premarket notification for "Disposable Powder Free Vinyl Examination Gloves, with Vitamin E." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

Ask a specific question about this device