(20 days)
Laglove™ Brand Latex Examination Glove (1) 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 Powdered Examination Gloves with 80 Micrograms or Less of Total Water Extractable Protein Per Gram
I apologize, but the provided text from the FDA 510(k) letter for "Laglove™ Brand Latex Powdered Examination Gloves" does not contain any information about acceptance criteria or a study proving the device meets said criteria.
This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device already on the market. It confirms the device's regulatory class and provides information about general controls. It does not detail specific performance metrics, clinical studies, or the methodologies used to assess those metrics.
Therefore, I cannot provide the requested information based on the input 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.