(81 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.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
This document is a 510(k) premarket notification for "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." It is a regulatory clearance letter from the FDA, and as such, it does not contain information about specific acceptance criteria or a study proving device performance in the way requested.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined it is as safe and effective as a device that was on the market before May 28, 1976, or has been reclassified. This determination is based on the information provided in the 510(k) submission, which typically includes comparisons to a predicate device regarding materials, design, and performance characteristics, but not necessarily a new clinical study with the detailed elements you've requested.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document doesn't detail specific performance metrics or acceptance criteria for the gloves beyond their intended use.
- Sample size used for the test set and the data provenance: Not applicable, as a new performance study is not detailed.
- Number of experts used to establish the ground truth... and qualifications: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a medical device (gloves), not an AI algorithm.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on the regulatory aspects of device clearance based on substantial equivalence, rather than detailed performance study results.
§ 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.