(97 days)
The Vinyl compound examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Vinyl compound examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is Blue. The design of proposed device is addressing the standards as ASTM D6124. ASTM D5151, and ASTM D5250. The proposed device is not provided as sterilized. The proposed device is made of vinyl chloride.
This document is a 510(k) premarket notification for "Vinyl compound examination gloves." It focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness or diagnostic accuracy of an AI device. Therefore, many of the requested categories related to AI studies, ground truth, expert adjudication, and comparative effectiveness are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria (from D5250) | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes | No water leakage is inspected from 200 samples |
| ASTM D6124 | Determine the powder residue for powder free 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.