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510(k) Data Aggregation
(379 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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific points:
Acceptance Criteria and Device Performance
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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(314 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 an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)
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 |
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