(27 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 5250-06e1.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)":
This is a 510(k) summary for medical gloves, which are low-risk devices. As such, the "study" demonstrating the device meets acceptance criteria is primarily based on non-clinical performance testing against established standards, rather than a complex clinical trial.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimension: ASTM standard D 5250-06 e1 | Meets |
| Physical Properties: ASTM standard D 5250-06 e1 | Meets |
| Freedom from pinholes: 21 CFR 800.20 | Meets |
| Powder Residual: ASTM standard D 5250-06 e1 and D6124-06 | 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.