(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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow):
Acceptance Criteria and Device Performance Study
The information provided describes the non-clinical testing performed to establish substantial equivalence for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties (e.g., tensile strength, elongation) | ASTM standard D 5250-06 | Meets |
| Freedom from Pinhole | 21 CFR 800.20 (Water Leak Test AQL) | Meets |
| 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.