(124 days)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (S"), medium (M"), large (L"), X-large (XL") for optional. The gloves are provided with blue color. The examination glove is smooth surface and a rolled rim at the cuff edge. The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
This document is a 510(k) summary for a medical device (ZinRom powder-free nitrile examination gloves), not an AI/ML medical device. Therefore, the requested information (acceptance criteria and study details for an AI/ML device) is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physical properties and biocompatibility for a physical product (gloves). It explicitly states "No clinical study is included in this submission."
Consequently, I cannot provide a table of acceptance criteria and reported device performance for an AI/ML device, nor details about sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML.
§ 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.