(232 days)
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) are disposable devices which made of poly(vinyl chloride) polymer compound, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between pattent and examiner and they meets all of the requirements of ASTM standard D 5250-06 el .
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06e1 | Meets |
| Physical Properties | ASTM standard D 5250-06e1 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06e1 and D6124-01 | Meets ( |
§ 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.