(110 days)
A Powder Free 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 for use with chemotherapy drug and Fentanyl Test Claim. In addition these gloves were tested for use with Chemotherapy drug and Fentanyl Citrate Tested claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drug and Fentanyl Citrate Tested Claim.
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
The provided document is a 510(k) premarket notification for a medical device: "Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim." This document focuses on the regulatory clearance process for a common medical device (gloves) and does not contain information about software acceptance criteria, study design for AI/ML algorithms, or human reader performance studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including information about:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information is typically found in submissions for AI/ML-driven medical devices, clinical trials for novel diagnostics or therapies, or performance studies for complex medical equipment. The provided document details the testing of the glove's barrier properties against specific chemotherapy drugs and fentanyl, based on ASTM D6978-05 standards, to support its intended use. The "acceptance criteria" here are the breakthrough times listed in the table for various chemotherapy drugs and fentanyl.
§ 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.