Search Results

A glove to be worn by operating room personnel to protect a surgical wound from contamination.

Not Found

The provided text is a 510(k) premarket notification for a medical device: "OmniGrip Latex Surgeons Gloves, Powder Free". This document is an FDA letter confirming substantial equivalence to a predicate device, which means no new clinical studies were likely performed to prove the device's efficacy or safety.

Therefore, the following information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

This document primarily states that the OmniGrip Latex Surgeons Gloves, Powder Free, are "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and compliance with general controls regulations (such as annual registration, device listing, good manufacturing practices, and labeling), rather than new performance studies with specific acceptance criteria and detailed study data.

Ask a specific question about this device