(227 days)
A patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Green Polychloroprene Examination Gloves, Powder-Free Blue Polychloroprene Examination Gloves, Powder-Free Brown Polychloroprene Examination Gloves
This document is a 510(k) premarket notification from the FDA regarding "Powder-Free Green Polychloroprene Examination Gloves," "Powder-Free Blue Polychloroprene Examination Gloves," and "Powder-Free Brown Polychloroprene Examination Gloves." It is a regulatory approval letter, not a study describing the acceptance criteria and performance of a device, especially not an AI/ML-based medical device.
Therefore, I cannot provide the requested information because the document does not contain details about:
- A table of acceptance criteria and reported device performance (in the context of AI/ML or clinical efficacy)
- Sample sizes for test sets or data provenance
- Number of experts or their qualifications for establishing ground truth
- Adjudication methods
- Multi-reader multi-case (MRMC) studies or effect sizes
- Standalone algorithm performance
- Types of ground truth used
- Sample size for training sets
- How ground truth for training sets was established
This document is solely an FDA clearance letter for a medical device (examination gloves), confirming its substantial equivalence to previously marketed devices based on its intended use as a barrier to prevent contamination. It does not describe a performance study for complex diagnostic or AI-driven devices.
§ 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.