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Powder Free Nitrile Patient Examination Gloves,Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.
The provided document describes the acceptance criteria and the study conducted for the "Powder Free Nitrile Patient Examination Gloves, Blue Color." This is a medical device, and the evaluation focuses on its physical and biological properties.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
Characteristics | Standard (Acceptance Criteria) | Device Performance |
---|---|---|
Dimension | ASTM standard D 6319 00a (2005)e1. | Meets |
Physical Properties | ASTM standard D 6319 00a (2005)e1. | Meets |
Freedom from pinholes | 21 CFR 800.20 | Meets |
Powder Residual | ASTM standard D 6319 00a (2005)e1. and D6124-06 | Meets ( |
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