(56 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Based on the provided document, the device in question is "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)". This summary is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical efficacy studies typical for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Powder Free Vinyl Patient Examination Gloves" are defined by various standards and regulations. The reported device performance indicates compliance with these standards.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets (Waterleak test on pinhole AQL) |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 |
§ 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.