(79 days)
The Powder Free Latex Examination Gloves 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 Latex Examination Gloves
This document is a marketing authorization letter from the FDA for a medical device (examination gloves). It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced diagnostic or AI-powered devices. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices, a regulatory pathway under 510(k).
Therefore, I cannot provide the requested information from this document. The document doesn't describe:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How 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.