(14 days)
A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.
The provided document describes the 510(k) summary for the Palm-Pro and Palm-Pro Premium Powder-Free Latex Examination Gloves. These gloves are Class I devices and their acceptance criteria and performance are outlined in relation to established ASTM standards and FDA regulations.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-01a | Meets (Same as predicate) |
| Physical Properties | ASTM D 3578-01a | Meets (Same as predicate) |
| Freedom from pinholes | ASTM D-3578-01a & FDA 21 CFR 800.20 | Meets (Same as predicate) |
| Powder-Free level | ASTM D 6124-01 |
§ 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.