(16 days)
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material, intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device, organized according to your requested information:
Description of Acceptance Criteria and Proving Study
This submission describes the acceptance criteria and performance for "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)". The device's performance is demonstrated through nonclinical testing against established ASTM standards and FDA regulations, as clinical data is explicitly stated as not being needed for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | 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.