(14 days)
A 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.
The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.
1. Acceptance Criteria and Device Performance:
| Characteristics | Standards (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00aEI | Meets |
| Physical Properties | ASTM D 6319 – 00dEI | Meets |
| Freedom from pinholes | ASTM D 6319 – 00dEI | |
| FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM D 6124 – 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.