(49 days)
The 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 blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
The provided documentation describes the acceptance criteria and performance of the "Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. This device is a patient examination glove used to prevent contamination between patient and examiner.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D5151 & ASTM D6319 | Meets |
| Powder Residual | ASTM D6124 (acceptance criteria typically |
§ 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.