(36 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
Here's a breakdown of the acceptance criteria and study information for the Zibo Hongye Shangqin Plastic & Rubber Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored), based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimension | Meets ASTM standard D 5250-00e4. |
| Physical Properties | Meets ASTM standard D 5250-00e4. |
| Freedom from pinholes | Meets 21 CFR 800.20 (waterleak test on pinhole AQL) |
| Powder Residual | Meets ASTM standard D 5250-00e4, |
§ 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.