(49 days)
The 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 black nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
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1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria (from Standard) | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM D6319-10 | (Implicitly, compliance with all dimensional specifications in ASTM D6319-10) | Meets (meaning it complies with ASTM D6319-10) |
| Physical Properties | ASTM D6319-10 | (Implicitly, compliance with all physical property specifications in ASTM D6319-10) | Meets (meaning it complies with ASTM D6319-10) |
| Freedom from Pinholes | ASTM D5151-06 & ASTM D6319-10 | (Implicitly, compliance with pinhole requirements in ASTM D5151-06 and D6319-10) | Meets (meaning it complies with both ASTM D5151-06 and D6319-10) |
| Powder Residual | ASTM D6124-06 | (Implicitly, compliance with powder residual limits in ASTM D6124-06, specifically |
§ 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.