(204 days)
A 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.
The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
This document describes the technical characteristics and performance of "Powdered, Natural Color, Latex Examination Gloves, Non-Sterile" produced by Best Putra Gloves Sdn Bhd. It serves as a 510(k) summary for clearance by the FDA.
1. Acceptance Criteria and Reported Device Performance
The device is assessed against ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test. The table below outlines the specific characteristics and their performance:
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | D 3578-01a€ | Meets |
| Physical Properties | D 3578-01a€ | Meets |
| Freedom from Pinhole | D 3578-01a€, FDA CFR 800.20 | Meets |
| Powder Amount | D 3578-01a€, D 6124 - 05 |
§ 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.