(133 days)
Powder Free Nitrile Patient Examination Gloves, White Color is a non-sterile 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, White Color are made of synthetic rubber, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device meets all of the requirements of ASTM standard D 6319 00a (2005)e1.
The acceptance criteria and study proving the device meets these criteria are described below.
1. Acceptance Criteria and Device Performance
The device is "Powder Free Nitrile Patient Examination Gloves, White Color". The acceptance criteria and reported device performance are presented in the table below:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319 00a (2005)e1. | Meets |
| Physical Properties | ASTM standard D 6319 00a (2005)e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319 00a (2005)e1. 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.