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The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested chemotherapy drugs are as follows:
Cisplatin, 1.0 mg/ml ≥ 240
Cyclophosphamide (Cytoxan), 20.0 mg/ml ≥ 240
Cytarabine, 100 mg/ml ≥ 240
Cytovene, 10 mg/ml ≥ 240
Dacarbazine (DTIC), 10.0 mg/ml ≥ 240
Docetaxel, 10.0 mg/ml ≥ 240
Doxorubicin Hydrochloride, 2.0 mg/ml ≥ 240
Etoposide (Toposar), 20.0 mg/ml ≥ 240
Fluorouracil, 50.0 mg/ml ≥ 240
Ifosfamide, 50.0 mg/ml ≥ 240
Irinotecan Hydrochloride, 20 mg/ml ≥ 240
Mechlorethamine HCI, 1.0 mg/ml ≥ 240
Methotrexate, 25 mg/ml ≥ 240
Mitomycin C, 0.5 mg/ml ≥ 240
Mitoxantrone, 2 mg/ml ≥ 240
Oxaliplatin, 5mg/ml ≥ 240
Paclitaxel (Taxol), 6.0 mg/ml ≥ 240
ThioTEPA 75.8
Vincristine Sulfate, 1.0 mg/ml ≥ 240
Vinorelbine, 10 mg/ml ≥ 240
Low Permeation Time (minutes) 1.7
Carmustine (BCNU), 3.3 mg/ml
Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)

Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices.

The provided text is a 510(k) summary for "Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim." This document describes the device's characteristics and performance to demonstrate substantial equivalence to a predicate device. It is not an AI/ML device, and therefore several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance Study for Powder-Free Nitrile Examination Gloves

This device is not an AI/ML device, and thus many of the requested sections related to AI/ML study design are not applicable. The device is a physical medical glove.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the individual tests (e.g., number of gloves tested for each characteristic or drug permeation). The tests were performance-based, carried out according to ASTM standards for physical device properties and chemical resistance.

• Data Provenance: The tests were conducted by Latexx Manufacturing Sdn. Bhd., located in Malaysia. The document doesn't specify if the data itself originated from Malaysia or another country, but the manufacturing site is in Malaysia. The studies are retrospective from the perspective of being submitted for regulatory approval, as they were completed prior to the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is a physical device, and the "ground truth" is established by performance against pre-defined standardized physical and chemical tests (e.g., ASTM standards for tensile strength, elongation, dimensions, and chemotherapy drug permeation), not by expert interpretation of data.

4. Adjudication Method for the Test Set

N/A. Not applicable for a physical device undergoing standardized mechanical and chemical testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

N/A. This is not an AI/ML diagnostic device; it is a physical medical glove.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. This is not an AI/ML device. The tests performed are inherent to the material properties and design of the glove.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by standardized laboratory testing procedures defined by international and national standards (e.g., ASTM D6319-10, ASTM D6124-06, ASTM D6978-05, ISO 10993-0:2002E, ASTM-F 720-81, 21 CFR 800.20). These standards define the methodology for measuring characteristics like dimensions, physical properties, biocompatibility, watertight integrity, and resistance to chemotherapy drug permeation.

8. The Sample Size for the Training Set

N/A. This is a physical device, not an AI/ML algorithm that requires a training set. The device itself is manufactured, and its performance is tested against standards.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable for a physical device.

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