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510(k) Data Aggregation
(21 days)
Powdered Free Vinyl Patient Examination Gloves, Light Yellow 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.
Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
This section describes acceptance criteria and the study proving the device meets said criteria.
The device under consideration is "Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color."
- Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 |
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(110 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 is a summary of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets standard | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets standard | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets standard (likely AQL for waterleak test) | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-01 |
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