(93 days)
The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.
Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs
The provided document is a 510(k) premarket notification letter from the FDA to Hartalega Sdn. Bhd. for "Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs."
This document does not contain information about an AI/ML device or a study proving its performance against acceptance criteria. Instead, it details the FDA's clearance of a medical device (examination gloves) based on a determination of substantial equivalence to a predicate device.
The "acceptance criteria" discussed in the document relate to the gloves' permeation resistance to chemotherapy drugs, which is a functional performance metric, not an AI/ML diagnostic or predictive metric. The study mentioned is a "Permeation Test" for these gloves, not a clinical study involving human readers or AI algorithms as described in your request.
Therefore, I cannot fulfill your request using the provided text because it does not describe an AI/ML device or a study of that nature.
Here's a breakdown of why this document doesn't fit your prompt:
- No AI/ML Device: The device is "Nitrile Powder Free Examination Gloves (Orange)". There is no mention of any artificial intelligence, machine learning, software, or algorithm.
- No Acceptance Criteria for AI/ML Performance: The acceptance criteria are "Minimum Breakthrough Time" for various chemotherapy drugs, which are physical properties of the gloves.
- No Study of AI/ML Performance: The "study" referenced is a "Permeation Test", which assesses how long it takes for chemotherapy drugs to permeate the glove material.
- No Sample Size for Test Set (AI/ML): Not applicable.
- No Data Provenance (AI/ML): Not applicable.
- No Experts for Ground Truth (AI/ML): Not applicable.
- No Adjudication Method (AI/ML): Not applicable.
- No Multi Reader Multi Case (MRMC) Study: Not applicable.
- No Standalone Performance (AI/ML): Not applicable.
- No Ground Truth Type (AI/ML): Not applicable.
- No Training Set Sample Size (AI/ML): Not applicable.
- No How Ground Truth for Training Set Established (AI/ML): Not applicable.
The table provided in the document ("Permeation Test Results of Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs") shows the results of the permeation tests against the implied criteria of preventing breakthrough within a certain timeframe (or demonstrating the breakthrough time).
If you have a document describing an AI/ML medical device and its performance study, I would be happy to analyze it according to your requested format.
§ 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.