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510(k) Data Aggregation
(80 days)
Powdered vinyl 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.
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
---|---|---|
Dimension | ASTM standard D 5250-06 | Meets |
Physical Properties | ASTM standard D 5250-06 | Meets |
Freedom from pinholes | 21 CFR 800.20 | Meets |
Powder Amount | ASTM standard D 5250-06 | Meets ( |
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(48 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
This document describes the acceptance criteria and the study conducted for "Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
---|---|---|
Dimension | ASTM standard D 5250-06 | Meets |
Physical Properties | ASTM standard D 5250-06 | Meets |
Freedom from pinholes | 21 CFR 800.20 | Meets |
Powder Residual | ASTM standard D 5250-06 and D6124-01 |
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