(125 days)
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specially glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate.
The K212613 gloves are produced as nitrile synthetic gloves. They are manufactured without natural rubber latex. The nitrile gloves are blue in color, disposable, single-use only, non-sterile, medical examination gloves. K212613 meets all the requirements of ASTM D6978-10(2019) Standard Specifications for Examination Gloves for Medical Applications. They have been tested for use with chemotherapy drugs and the opioid Fentanyl citrate, both of which were evaluated using ASTM D6378-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The provided document describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue). The evaluation is based on non-clinical performance tests, not clinical studies involving human or animal subjects. Therefore, sections related to human reader studies, ground truth establishment by experts, and training set information are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6978-2005 (2019) | Permeation by Chemotherapy Drugs | Minimum breakthrough detection time > 240 minutes for most drugs | All Chemotherapy Drugs & the Opioid passed >240 min except Carmustine (13.0 min) & ThioTepa (37.9 min) |
| ASTM D412-2016 | Physical properties (Tensile strength) | Minimum 14 Mpa | Pass |
| ASTM D412-2016 | Physical properties (Elongation) | Minimum 400% | Pass |
| ASTM D5151-19 | Water-leak test | AQL 1.5 (ISO 2859-1) | Pass |
| ASTM D6124-06 (2017) | Residual powder test |
§ 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.