(45 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 5250-00-4
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)
Summary of Device Performance Study:
The provided text describes a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies for Class I devices like examination gloves. The "study" in this context refers to the nonclinical tests conducted to prove the device meets established standards and is comparable to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 & 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.