(95 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed.
The document describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" manufactured by Tangshan Luxiong Plastic Products Co.,Ltd. The submission is a 510(k) premarket notification, indicating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard | Acceptance Criteria | Device Performance |
|---|---|---|---|
| Dimension | ASTM D 5250-00e4 | Meets ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM D 5250-00e4 | Meets ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 5250-00e4, 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.