(30 days)
The Powder Free Blue Nitrile Examination Glove, Non Sterile 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 Powder Free Blue Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 and FDA 21 CFR 800.20.
Here's a breakdown of the acceptance criteria and study information for the WRP Asia Pacific Sdn Bhd's Powder Free Blue Nitrile Examination Gloves, Non-Sterile, based on the provided document:
This document is a 510(k) summary for a medical device (examination gloves), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study report for a novel AI device. Therefore, many of the requested categories for AI/software studies are not applicable.
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 - 00aE3 | Meets |
| Physical Properties | ASTM D 6319 - 00aE3 | Meets |
| Freedom from pinholes | ASTM D 6319 - 00aE3 & FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets ( |
§ 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.