(21 days)
Laglove™ Brand Latex Examination Glove (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Laglove™ Brand Latex Examination Gloves (Powder Free) contains 50mcgm less of total water extractable protein per gram.
The provided document is an FDA 510(k) clearance letter for a latex examination glove, not a study describing the acceptance criteria and performance of a medical device in the context of an AI/algorithm-based system.
Therefore, I cannot extract the requested information because the document does not contain:
- A table of acceptance criteria and reported device performance for an AI/algorithm.
- Information about sample sizes for test sets, data provenance, or training sets in the context of an AI study.
- Details regarding expert ground truth establishment, adjudication methods, or MRMC studies.
- Mention of standalone performance or the type of ground truth used for AI training.
The document is a regulatory approval for a physical product (gloves) based on substantial equivalence to a predicate device, not on the performance of a diagnostic algorithm or AI system.
§ 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.