(96 days)
Powder-Free Butadiene Copolymer Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
This product has a pH of 5.5, which is an integral part of this patented product. This is not an antimicrobial/antiseptic glove.
This device is not intended to be used as a chemical barrier.
Powder-Free Butadiene Copolymer Examination Gloves, Violet Color
The provided text is a 510(k) premarket notification letter from the FDA to Shen Wei (USA), Incorporated, concerning their "Powder-Free Butadiene Copolymer Examination Gloves with Aloe, Violet Color." This document is a regulatory approval and does not describe a study that uses AI/ML for medical device performance evaluation.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI, as this document pertains to a traditional medical device (gloves) and their regulatory clearance based on substantial equivalence, not AI/ML performance evaluation.
§ 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.