(51 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.
This is a submission for a patient examination glove, which is a Class I medical device. The information provided is primarily related to non-clinical performance testing against established standards, and therefore, many of the requested categories regarding clinical studies, expert adjudication, and AI performance are not applicable.
Here's the breakdown of the available information:
Acceptance Criteria and 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 |
§ 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.