(88 days)
A powder-free 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.
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
The provided document is a 510(k) premarket notification letter from the FDA for Powder-Free Nitrile Examination Gloves. This type of document is a regulatory approval for a medical device and therefore primarily focuses on compliance with regulations and substantial equivalence to a predicate device.
It does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. The document is for a physical patient examination glove, not a software or AI-driven device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth establishment
- Adjudication method for the test set
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size and ground truth establishment for the training set
This document pertains to the regulatory clearance of a physical medical device (gloves) and such information is not applicable or present within this text.
§ 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.