(121 days)
Powder Free Blue Patient Nitrile Examination Gloves 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.
Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6319-05
The provided document describes the acceptance criteria and the study conducted for the Nitrile Powder Free Patient Examination Gloves (Blue). This is a medical device subject to regulatory clearance, and the study focuses on non-clinical performance to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319-05 | Meets |
| Physical Properties | ASTM standard D 6319-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-01 |
§ 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.