(120 days)
POWDER TREE NITRILE EXAMINATION GLOVES, BLUE NON STERILE is a disposable device and make of Synthetic Is a Gropodosatibits rubber like Characteristics Intended For Medical Purpose that is worn on the Incended roz finger to prevent contamination between patient and examiner -
The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.
The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Blue Examination Gloves, Blue, Non Sterile." This is a medical device and not an AI/ML powered device, so many of the requested fields are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimension | D 6319-00aE3 | Meets D 6319-00aE3 | Meets |
| Physical Properties | D 6319-00aE3 | Meets D 6319-00aE3 | Meets |
| Freedom from Pinholes | D 6319-00aE3, FDA 21 CFR 800.20 | Meets D 6319-00aE3, FDA 21 CFR 800.20 | Meets (specifically, FDA 1000 ml Water Leak Test and Pinhole AQL) |
| Powder Residue | D 6319-00aE3, D6124 - 01 |
§ 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.