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Biopro™, Correct Touch® (Powdered) is a medical glove which is worn on the hand of health care and similar personnel to prevent contamination between patient and the examiner.

Latex Powdered Examination Glove

This document is a marketing clearance letter for Latex Powdered Examination Gloves. As such, it does not contain the detailed technical study information like performance data, ground truth establishment, or sample sizes for AI/algorithm-based devices. The request is for information on a device and its acceptance criteria and the study that proves the device meets the acceptance criteria. This document is a regulatory approval for a physical medical device not a software medical device. The information requested (acceptance criteria, details of a study with sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) are specific to the validation of software algorithms or AI-based medical devices. This document pertains to traditional physical medical devices.

Therefore, most of the requested information cannot be extracted from this document, as it outlines marketing approval based on substantial equivalence for a physical glove, not a software device's performance study.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable/Not available. This document does not detail specific performance criteria for the latex glove beyond its intended use for preventing contamination. The primary "acceptance criteria" here is substantial equivalence to a legally marketed predicate device, not performance metrics based on a clinical or technical study.

2. Sample size used for the test set and the data provenance: Not applicable/Not available. No test set or data provenance details are provided as this is not a software device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not available. No ground truth establishment by experts is described for a latex glove.

4. Adjudication method: Not applicable/Not available. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/Not available. This type of study is for diagnostic software devices.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not available. This is not a software algorithm.

7. The type of ground truth used: Not applicable/Not available. Ground truth, in the context of AI/software, is not relevant for a physical medical glove. Its approval is based on material properties, manufacturing standards, and substantial equivalence.

8. The sample size for the training set: Not applicable/Not available. There is no training set for a physical glove.

9. How the ground truth for the training set was established: Not applicable/Not available. There is no training set or ground truth for a physical glove.

What the document does indicate regarding "acceptance":

The device (Latex Powdered Examination Glove) was accepted by the FDA based on substantial equivalence to devices marketed prior to May 28, 1976. This is the primary regulatory "acceptance criteria" for this type of device and submission (510(k)).

The "study that proves the device meets the acceptance criteria" in this context refers to the 510(k) submission itself, which demonstrates substantial equivalence, typically through comparison of physical and chemical properties, intended use, and performance claims (e.g., barrier integrity, biocompatibility) to a predicate device, rather than a clinical performance study with human readers or AI algorithms. The document does not provide the specifics of how that substantial equivalence was demonstrated (e.g., specific test results on barrier integrity, tensile strength, etc.), as it is merely the clearance letter.

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