(224 days)
Flexaprene Green Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Flexaprene Green Powder-Free Exam Glove
I am sorry, but based on the provided text, I cannot provide the requested information. This document is a 510(k) clearance letter from the FDA for a medical device (Flexaprene Green Powder-Free Exam Glove). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.
The document does not contain information about:
- Acceptance criteria and reported device performance for a study. It only states the device's indications for use.
- Sample sizes used for test sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
This document is a regulatory approval notice, not a study report detailing performance metrics and validation processes.
§ 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.