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A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

The powder-free latex exam glove with vitamin E and aloe meets the current specifications for ASTM D 3578-00a. The powder-free latex exam gloves with vitamin E and aloe are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.

The provided document is a 510(k) summary for a medical device, specifically the "SAFESKIN HEALTHTOUCH" Powder-Free Latex Exam Glove with Vitamin E and Aloe. It outlines the device's characteristics and its equivalence to a predicate device, as well as the FDA's approval.

Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:

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

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

The document does not specify sample sizes for individual tests (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). It only states that the "performance test data... are described above" [8].

Data provenance is not explicitly mentioned as country of origin, nor whether the data is retrospective or prospective. It is implied to be data collected to support this specific 510(k) application.

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

This information is not applicable to this type of device and study. This is a medical glove, and its performance is evaluated against standardized physical and chemical tests (ASTM standards) and biocompatibility tests, not against expert human interpretation of medical images or patient outcomes. The "ground truth" is defined by the objective pass/fail criteria of the ASTM standards and biocompatibility tests.

4. Adjudication method for the test set

This is not applicable. The evaluation of exam glove performance against ASTM standards and biocompatibility tests does not involve human adjudication in the way medical image analysis or clinical trials might. The results are objective measurements against defined criteria.

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 is not applicable. This document is for a physical medical device (exam gloves), not an AI-powered diagnostic or decision support system. Therefore, no MRMC study or AI-related comparative effectiveness analysis was conducted or is relevant.

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

This is not applicable. As mentioned above, this is not an AI device.

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

The "ground truth" for this device's performance is established by objective, standardized measurements and tests against the specific ASTM standards listed (e.g., ASTM D 3578-00a, ASTM D 5151-99, ASTM D 6124-00a, ASTM D 5712-99) and common biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These standards define what constitutes acceptable performance for dimensions, physical properties, freedom from pinholes, powder content, protein content, and lack of adverse biological reactions.

8. The sample size for the training set

This is not applicable. This is not a machine learning or AI device, so there is no concept of a "training set" in the context of this 510(k) submission.

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

This is not applicable for the same reasons as #8.

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