(149 days)
The Halyard ® Fusion Black Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Halyard® Fusion Black Powder-Free Nitrile Exam Gloves are disposable, black-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves which are chlorinated on the donning side and are packed in a cardboard dispenser box.
Here's a breakdown of the acceptance criteria and study information for the Halyard® Fusion Black Powder-Free Nitrile Exam Glove, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves | Meets the 2.5 AQL (Acceptable Quality Level) requirement for leakage. | Testing of the subject device shows it meets the 2.5 AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. |
| ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications | Physical dimensions are within the standard limits. Physical properties (tensile strength and elongation) meet the standard requirements. | The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. Therefore, the device meets the acceptance criteria of the standard. |
| ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves | Residual powder is within the powder-free limit of |
§ 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.