(401 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES & Nopal + Vitamin C
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Opus-E Disposable powder Free Vinyl synthetic Exam Gloves with Nopal & Vitamin E". This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or clinical trial details.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory declaration, not a detailed performance study summary.
§ 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.