(108 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 a breakdown of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" based on the provided text, structured according to your requested points:
Acceptance Criteria and Device Performance Study
The submission details the non-clinical testing performed to demonstrate that the Powder Free Vinyl Patient Examination Gloves meet predefined acceptance criteria and are safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | 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 |
| Powder Residual | ASTM standard D 5250-06 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.