(186 days)
A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.
The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
The provided document outlines the acceptance criteria and performance of a device, but it is not a study in the typical sense of a clinical trial or comparative effectiveness research. Instead, it is a 510(k) Premarket Notification Summary for a medical device (Powdered Latex Examination Gloves, Non Sterile), which aims to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 3578-01ae2 | Meets |
| Physical Properties | ASTM D 3578-01ae2 | Meets |
| Freedom from Pinholes | ASTM D 3578-01ae2 | |
| FDA 21 CFR 800.20 (1000 ml Water Leak Test) | Meets | |
| Powder Residue | ASTM D 3578-01ae2, 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.