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Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is available in Small, Medium, Large and Extra Large sizes. The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

The provided document is a 510(k) premarket notification for "Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate." This document outlines the acceptance criteria and the results of a study to demonstrate the device's performance.

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

1. A table of acceptance criteria and the reported device performance

The document provides extensive tables for the performance of the gloves. Rather than recreating the entire tables found on pages 10-14, a summary of key acceptance criteria and reported performance is presented below. Please refer to pages 10-14 of the original document for the complete lists of chemotherapy drugs and specific results.

Note on Cytotoxicity: The device itself is reported as cytotoxic under the tested conditions. This is a critical finding that does not meet a "Non cytotoxic" acceptance criterion. However, the FDA has still cleared the device. This implies that either the level of cytotoxicity observed is deemed acceptable for the intended use and risk-benefit profile of examination gloves, or mitigating factors/information were provided elsewhere (not in this summary). It's important to note this discrepancy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists various ASTM and ISO standards for testing, which define the sample sizes required for each test (e.g., AQL levels for watertightness). However, the specific quantity/sample size used for each individual test conducted by the manufacturer is not explicitly stated in this summary document beyond what's implied by the standard (e.g., AQL 1.5 for watertightness performance is a characteristic, not a sample size).

• Data Provenance: The manufacturing location of the device owner, JR Engineering & Medical Technologies (M) Sdn. Bhd., is in Malaysia (Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor Darul Ehsan, Malaysia). The testing was conducted in accordance with international standards (ASTM, ISO), implying that the data originates from laboratory studies, likely conducted by third-party labs or the manufacturer's own qualified labs, but the specific country of the testing labs is not mentioned.
• Retrospective or Prospective: The testing described is prospective laboratory performance testing of the device, rather than a retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a medical glove, not an AI or imaging device requiring expert consensus for ground truth. The "ground truth" for this device's performance is established through objective, standardized laboratory testing (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 for biocompatibility). These tests rely on chemical and physical measurements, not human expert interpretation of images or clinical outcomes. Therefore, the concept of "number of experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" is not applicable to this type of device. The "experts" are the technicians and scientists performing the standardized validation tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary (like in imaging diagnosis), there is no adjudication method described.

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 device is a physical examination glove, not an AI or imaging diagnostic tool that would involve human readers or 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. The tests performed are "standalone" in the sense that they assess the intrinsic material properties and barrier performance of the glove itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device is based on standardized, objective physical, chemical, and biological measurements obtained through laboratory testing, as defined by relevant ASTM and ISO standards. This includes:

• Physical measurements (e.g., length, width, thickness, tensile strength, elongation).
• Chemical analysis (e.g., residual powder, breakthrough detection time for drugs).
• Biological testing (e.g., irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity).

8. The sample size for the training set

Not applicable. This device is a manufactured product (glove), not an AI algorithm or model that requires a "training set" of data.

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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JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examination between patient and examiner.

Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

The subject device in 510(K) notification is JR Medic blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I).

The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

I am sorry, but the provided text does not describe a study involving an AI device or algorithm, and therefore all the requested information about acceptance criteria, study design, sample sizes, ground truth, expert involvement, and MRMC studies cannot be extracted.

The document is a 510(k) premarket notification for "JR Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs." It details the non-clinical testing performed on these medical gloves to demonstrate their safety and effectiveness, specifically their resistance to permeation by chemotherapy drugs, in accordance with established ASTM (American Society for Testing and Materials) standards.

The document focuses on the physical, chemical, and biocompatibility properties of the gloves, not on the performance of a software algorithm or AI.

Ask a specific question about this device