(49 days)
Powdered 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.
powdered vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.
The provided document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)". This is a Class I medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information details the acceptance criteria and the methods used to prove the device meets these criteria.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Defined by ASTM D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Defined by ASTM D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Defined by 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Defined by ASTM D 5250-00e4 (specifically |
§ 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.