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

STERILE PATIENT EXAMINATION GLOVES - POWDERFD

This document is a 510(k) clearance letter from the FDA for "Sterile Patient Examination Gloves, Powdered." It is not a study report or a document describing the acceptance criteria or performance of a medical device based on a clinical or technical study.

Therefore, most of the requested information cannot be extracted from the provided text. The document primarily serves as an official notification that the device has been deemed "substantially equivalent" to predicate devices and can be marketed.

Here's what can be gathered and what cannot:

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

• Cannot be extracted. This document does not contain acceptance criteria for performance benchmarks, nor does it report specific device performance data. The 510(k) process for patient examination gloves typically relies on adherence to recognized standards (e.g., ASTM standards for physical properties, biocompatibility) rather than complex clinical studies with performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI devices. The substantial equivalence determination means it met these standards but the specific acceptance criteria and performance data are not detailed here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted. No test set, sample size, or data provenance is mentioned as this is not a study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be extracted. This information is irrelevant to a 510(k) clearance for examination gloves.

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

• Cannot be extracted. Not applicable to this type of regulatory document.

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

• Cannot be extracted. This document is for examination gloves, not an AI-powered diagnostic device. MRMC studies are not relevant here.

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

• Cannot be extracted. This document pertains to a physical medical device (gloves), not a software algorithm.

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

• Cannot be extracted. No ground truth defined in this context. Substantial equivalence for gloves typically relies on compliance with material specifications, mechanical properties, and biocompatibility standards.

8. The sample size for the training set

• Cannot be extracted. No training set is involved for this type of device and regulatory submission.

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

• Cannot be extracted. Not applicable.

Summary from the provided document:

The provided text is an FDA 510(k) clearance letter for "Sterile Patient Examination Gloves, Powdered." It confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. The letter explicitly states the device's indications for use: "An 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."

This document does not contain information about specific performance data, acceptance criteria metrics, sample sizes for studies, expert qualifications, or details typically found in scientific study reports for complex medical devices or AI algorithms.

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