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This device is intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin, 1.0 mg/ml (1,000 ppm); Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm); Dacarbazine, 10.0 mg/ml (10,000 ppm); Doxorubicin HCI, 2.0 mg/ml (2,000 ppm); Etoposide, 20.0 mg/ml (20,000 ppm); Fluorouracil, 50.0 mg/ml (50,000 ppm); Paclitaxel, 6.0 mg/ml (6,000 ppm). Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3.300 ppm), 23.9minutes; ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes. WARNING: Do not use Carmustine and Thiotepa

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves. It does not contain any information about an AI/ML device or a study proving its performance. Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device.

The document discusses:

• The clearance of "Disposable Medical Nitrile Examination Gloves - Tested for Use With Chemotherapy Drugs"
• The regulation number and product codes
• General controls provisions and other regulatory requirements for medical devices
• Indications for Use for the gloves, including specific chemotherapy drugs they were tested against and their breakthrough times.

There is no mention of acceptance criteria, study designs, sample sizes, expert involvement, ground truth, or any other elements related to the evaluation of an AI/ML-driven medical device.

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The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.

The provided text describes the 510(k) clearance for "Disposable Medical Nitrile Examination Gloves (Model: XYS-001)". This is a Class I medical device (non-powdered patient examination glove), and the submission focuses on demonstrating substantial equivalence to a predicate device.

The "study" described is a series of non-clinical bench tests and biocompatibility tests conducted to meet specific performance standards and criteria. There is no multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance study, or training set information as this is not an AI/software device.

Here's the breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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