(86 days)
The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
This document is a 510(k) summary for Vinyl Examination Gloves (Yellow). It does not describe an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human reader improvement, standalone performance, ground truth, and training set information is not applicable.
The document assesses the substantial equivalence of the Vinyl Examination Gloves (Yellow) to a predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves (White, Blue, Yellow), K163168).
The comparison focuses on physical dimensions, performance properties, material, and biocompatibility, demonstrating that the new device meets relevant ASTM and ISO standards for vinyl examination gloves.
§ 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.