(98 days)
Laglove TM Brand Nitrile Examination Gloves, Powdered, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
Laglove TM Brand Nitrile Examination Gloves, Powdered, Non-Sterile. (Pink Color)
The provided text is a 510(k) premarket notification letter from the FDA for Laglove™ Brand Nitrile Examination Gloves, Powdered, Non-Sterile (Pink). This document is a regulatory approval for a medical device and thus does not contain information about an AI/ML study, device performance, acceptance criteria, or ground truth establishment.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device meets acceptance criteria based on this document. This document pertains to the regulatory clearance of examination gloves, which are physical medical devices, not AI/ML systems.
§ 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.