(14 days)
Powdered 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.
powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004
The provided document describes the safety and effectiveness information for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)" submitted by ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD. The study presented is a non-clinical evaluation comparing the device's technical characteristics against established standards.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets 21 CFR 800.20 requirements (implying a specific AQL for waterleak test) | Meets |
| Powder Amount | ASTM standard D 5250-00e4 |
§ 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.