(70 days)
Powder free vinyl patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
The provided text describes the acceptance criteria and performance of the Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored). However, it does not include information about a "study" in the traditional sense of a clinical trial or a machine learning model's performance study with separate training and test sets, and expert ground truth establishment. This is a 510(k) premarket notification for a medical device (examination gloves), which primarily relies on conformance to established standards and comparison to a predicate device, rather than a novel algorithm's performance.
Here's a breakdown of the requested information based on the provided text, with explanations for what is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06e1 | Meets |
| Physical Properties | ASTM standard D 5250-06e1 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06e1 and D6124-06 | Meets ( |
§ 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.