(201 days)
Nitrile Powder Free Patient Examination Gloves, Blue 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.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The document describes the acceptance criteria and performance data for the "Nitrile Powder Free Patient Examination Gloves, Blue Color." The information is presented in the context of a 510(k) premarket notification, where the device's substantial equivalence to a predicate device is demonstrated through non-clinical performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard (Acceptance Criteria) | Device Performance | Result of Comparison |
|---|---|---|---|
| Dimension | ASTM standard D 6319-10. | Meets | Substantially equivalent |
| Physical Properties | ASTM standard D 6319-10. | Meets | Substantially equivalent |
| Freedom from Pinholes | 21 CFR 800.20 | ||
| ASTM D 5151-06 (Reapproved 2011) | Meets | ||
| Holes at Inspection Level I AQL 2.5 | Substantially equivalent | ||
| Powder Residual | ASTM standard D 6319-10 and D6124-06 (Reapproved 2011). | Meets |
§ 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.