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A powder-free, non-sterile patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES.

The provided document is a 510(k) premarket notification letter from the FDA to Quality Gallant SDN. BHD. regarding "Powder Free Nitrile (Dark Blue) Examination Gloves." This letter primarily addresses the regulatory approval of the device and its substantial equivalence to legally marketed predicate devices.

Crucially, this document does not contain information about acceptance criteria for a device's performance beyond regulatory requirements, nor does it detail a study that proves the device meets specific performance-based acceptance criteria in the context of a medical AI or diagnostic device. It focuses on the regulatory classification, general controls, and good manufacturing practices for examination gloves.

Therefore, I cannot provide the requested information from the provided text, as the document does not describe:

1. A table of acceptance criteria and reported device performance: The document only lists the device name, regulation number, and regulatory class. It doesn't present performance metrics like sensitivity, specificity, accuracy, or any other quantitative measures typically found in performance studies.
2. Sample size for the test set or data provenance: No performance testing data is presented.
3. Number of experts and their qualifications for ground truth: Not applicable, as there's no diagnostic performance study mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device (gloves), not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The "Indications for Use" section (page 3) defines the intended use of the gloves but does not include performance criteria or the results of studies demonstrating their fulfillment beyond the inherent properties of medical examination gloves.

In summary, the provided text concerns the regulatory clearance of medical examination gloves and does not offer the type of performance study details requested for an AI or diagnostic device.

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A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES

The provided text is a 510(k) Premarket Notification from the FDA for "Powder Free Nitrile (Blue and White) Examination Gloves." This document DOES NOT describe acceptance criteria or a study proving the device meets those criteria.

Instead, a 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This equivalence is typically based on:

• Same intended use.
• Same technological characteristics, OR
• Different technological characteristics but does not raise different questions of safety and effectiveness AND is as safe and effective as the predicate device.

For devices like examination gloves, equivalence is often established by demonstrating compliance with recognized consensus standards (e.g., ASTM standards for physical properties, barrier integrity, and biocompatibility). The FDA letter confirms the device's substantial equivalence to a predicate, allowing it to be marketed, but does not detail the specific performance criteria or studies that led to this determination within the provided text.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC comparative effectiveness studies from the provided text. This type of information would typically be found in the actual 510(k) submission document itself, not in the FDA's decision letter.

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A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

POWDER FREE LATEX EXMAINATION GLOVES

This document, K071322, is a 510(k) premarket notification for Powder Free Latex Examination Gloves. It is a regulatory clearance letter from the FDA, and as such, it does not contain the detailed technical study information typically found in a scientific publication or clinical trial report that describes acceptance criteria and device performance in the way requested.

Therefore, I cannot provide a direct answer to your request regarding acceptance criteria and a study proving the device meets them from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for this class of device based on comparisons to existing products, rather than presenting a novel study designed to establish new performance criteria.

Here's why each of your requested points cannot be extracted from this specific document:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., tensile strength, viral barrier effectiveness) or present results from tests against such criteria. It's a regulatory clearance letter, not a performance report.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned.
4. Adjudication method: Not applicable or mentioned.
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 physical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic "ground truth." For gloves, "ground truth" might refer to established physical properties and barrier effectiveness, but this document does not detail the testing.
8. The sample size for the training set: Not applicable. Examination gloves do not typically involve "training sets" in the machine learning sense.
9. How the ground truth for the training set was established: 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 purpos patient and examiner.

POWDERED LATEX EXMAINATION GLOVES

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powdered Latex Examination Gloves." This document primarily addresses regulatory approval and does not contain the detailed technical study information typically found in a device's performance evaluation.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document confirms market clearance based on substantial equivalence to a predicate device, but it does not include performance data, ground truth establishment, sample sizes, or expert adjudication methods.

Summary of what cannot be provided from the given text:

1. Table of acceptance criteria and reported device performance: Not present. The letter is a regulatory approval, not a performance report.
2. Sample size for the test set and data provenance: Not present.
3. Number of experts and qualifications for ground truth: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable or present. This device is a physical glove, not an AI or imaging device where MRMC studies are common.
6. Standalone (algorithm only) performance information: Not applicable or present.
7. Type of ground truth used: Not applicable or present.
8. Sample size for the training set: Not applicable or present.
9. How ground truth for the training set was established: Not applicable or present.

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