(111 days)
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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 Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10
This document is a 510(k) summary for a medical device called "Powder Free Nitrile Patient Examination Gloves, Blue Color." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6139-10 | Meets |
| Physical Properties | ASTM standard D 6139-10 | 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.