(127 days)
A 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 Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Device: Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Status | ISO11137-1:2006 (Non-Sterile) | Non-Sterile |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Thickness | ASTM D6319-10 | Meets |
| Powder Free | ASTM D6124-06 | 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.