(39 days)
A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the examiner's hand or finger's for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Powder-Free Polymer-Coated Latex Examination Gloves
The provided text describes a 510(k) premarket notification for "Ever-More Powder-Free Polymer-Coated Latex Examination Gloves." This is a regulatory document affirming substantial equivalence to a predicate device, not a study reporting on the performance of a medical device against acceptance criteria in the manner of AI/ML or imaging diagnostics.
Therefore, none of the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or training/ground truth establishment is present in the provided document.
The document details the regulatory classification of the device (Class I), its regulation number (880.6250), product code (LYY), and its intended use as a barrier against potentially infectious materials. It also confirms that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not available. This document is about regulatory clearance, not performance testing.
- Sample sizes used for the test set and data provenance: Not applicable. No test set described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth establishment for a test set.
- Adjudication method for the test set: Not applicable. No test set adjudication.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML or imaging diagnostic device.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a physical glove, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient 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. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.