(28 days)
A patient Vinyl Exam 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.
Vinyl, Patient Exam Gloves, Powdered
This document is a 510(k) clearance letter from the FDA for a Vinyl Powdered Examination Glove. It is primarily a regulatory communication and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) or de novo submission might.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- 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 document states the device is "substantially equivalent" to pre-amendments devices and focuses on regulatory compliance (GMP, labeling, etc.). For examination gloves, the performance criteria typically relate to things like barrier integrity (e.g., freedom from holes), tensile strength, and dimensions, which are usually tested according to industry standards, but these details are not present in this regulatory letter.
§ 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.