(47 days)
The powdered latex surgeon's glove with protein content labeling claim (200 micrograms or less per gram) is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.
Powdered Latex Surgeon's Glove with Protein Content Labeling Claim (200 Micrograms or Less per Gram)
The provided text is a 510(k) clearance letter from the FDA for a powdered latex surgeon's glove. It does not contain any information about acceptance criteria or a study that proves a device meets such criteria.
The document primarily states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory determination, not a statement about specific performance metrics relative to acceptance criteria from a study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to the regulatory clearance of a physical medical device (gloves), not an AI/software device that would typically undergo the kind of performance studies described in your query.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).