(207 days)
An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
This document is a 510(k) premarket notification for nitrile examination gloves and describes their performance against chemotherapy drugs and Fentanyl. It does not describe an AI/ML powered device, therefore, the requested information regarding AI/ML device acceptance criteria and study details cannot be extracted.
The document provides the following information:
- Device: Nitrile Examination Powder Free Glove, Blue and Black
- Intended Use: Disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and Fentanyl.
- Testing Standard: ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
- Performance Data: Tables showing the minimum breakthrough detection time in minutes for 32 chemotherapy drugs and Fentanyl for both blue and black gloves. Most drugs show a breakthrough time of >240 minutes, but Carmustine and Thiotepa have significantly shorter breakthrough times.
- Warnings/Cautions: Specific warnings against using Carmustine and cautions regarding the short breakthrough time for Thiotepa.
It does not contain information about:
- Acceptance criteria or studies for an AI/ML powered device.
- Sample sizes for test sets or data provenance in the context of AI/ML.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi Reader Multi Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth for AI/ML.
- Training set sample sizes or ground truth establishment for AI/ML.
§ 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.