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This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are:

Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.

Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes
Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Ifosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes
Vincristine Sulfate (1.0 mg/ml). Permeation time: no Breakthrough up to 240 minutes

DO NOT USE WITH CARMUSTINE OR THIOTEPA

The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs is provided in blue. It meets all the requirements of ASTM D6319-10. It is a 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 were tested for use with chemotherapy drugs per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.

This document is a 510(k) premarket notification for a medical device, specifically non-sterile examination gloves tested for use with chemotherapy drugs. It is a declaration of substantial equivalence to a predicate device and therefore does not include a study to "prove the device meets acceptance criteria" in the way a clinical trial or algorithm validation study would. Instead, it presents information to demonstrate that the new device shares similar characteristics and performs comparably to a device already legally marketed.

Here's an analysis based on the information provided, framed to address your request for acceptance criteria and study details where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that for this type of device (patient examination gloves), "acceptance criteria" primarily relate to compliance with established industry standards for glove properties and permeation resistance. The document doesn't explicitly state numerical acceptance criteria for all aspects in a centralized table, but rather implies compliance with ASTM standards and compares performance to a predicate device.

However, we can extract the key performance metrics and their "acceptance" (or rather, "demonstrated") values, particularly for chemotherapy drug permeation resistance.

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

This document describes a medical device, which is a physical product (gloves). The "test set" in this context refers to the samples of gloves subjected to various physical and chemical tests, not a dataset for an AI algorithm.

• Sample Size: Not explicitly stated as a single number. However, the use of standards like ASTM D6319-10, ASTM D6978-05, ASTM D5151-06, ISO 2859-1 (for sampling procedures), ASTM D412-16, ASTM D3767-03, and ASTM D573-04 implies that samples were chosen and tested in accordance with the methodologies prescribed by these standards, which define specific sample sizes for their respective tests (e.g., number of gloves for permeation, tensile strength, barrier integrity, etc.).
• Data Provenance: The document states the device is manufactured by "SEMPERIT INVESTMENTS ASIA PTE. LTD." located in Singapore and mentions "Made in Malaysia" on the labeling. The testing was conducted to international (ISO) and U.S. (ASTM) standards. This indicates the testing was likely conducted in an approved laboratory, possibly in Malaysia or another location accredited to perform these tests to the specified standards. The data is prospective in the sense that the new device was specifically manufactured and tested to demonstrate its properties.

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

This question is not applicable to this type of device submission. There isn't "ground truth" established by human experts in the context of diagnostic imaging or clinical assessment. The "truth" here is determined by objective, measurable physical and chemical properties as defined by the ASTM and ISO standards for examination gloves and their resistance to chemicals.

4. Adjudication Method for the Test Set

Not applicable. Physical and chemical tests typically follow predefined protocols. The results are quantitative measurements or qualitative observations reported by the testing laboratory, not subject to human adjudication in the way medical diagnoses are.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This is not an AI/software device. There are no "human readers" to compare performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device relies on:

• Defined Standards: Compliance with physical, mechanical, and chemical resistance properties as outlined in the referenced ASTM and ISO standards (e.g., ASTM D6319-10 for general glove properties, ASTM D6978-05 for chemotherapy drug permeation).
• Objective Measurement: Permeation times for chemotherapy drugs are determined through laboratory testing using established scientific methods, typically involving detection of the drug on the "inside" surface of the glove material after a certain exposure time. Similar objective measurements are used for tensile strength, barrier integrity, dimensions, etc.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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