(125 days)
A Synthetic Vinyl Examination Gloves, Powder-free, Yellow 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.
Synthetic Vinyl Examination Gloves, Powder-free, Yellow
This document is a 510(k) premarket notification decision letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free, Yellow". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. It is a regulatory approval letter, not a performance study report.
Therefore, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.