Search Results

Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.

Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10(2015) and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2013).

This document is a 510(k) summary for the "Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". It describes the device, its intended use, and comparative testing against a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily evaluated against two standards: ASTM D6319-10(2015) for Nitrile Examination Gloves (General Characteristics) and ASTM D6978-05(2013) for Chemotherapy Drug Permeation. Specific acceptance criteria are not explicitly stated for all parameters, but rather the performance of the proposed device is compared to the predicate device and relevant ASTM standards.

The table below summarizes the key performance characteristics and reported results. For characteristics not explicitly having acceptance criteria listed as a specific number, the "Comparison" column indicates if the device is "Same" or "Similar" to the predicate, implying it meets comparable performance.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of gloves or test replicates) used for each individual test (e.g., tensile strength, freedom from holes, chemotherapy permeation). It references the ASTM standards, which typically define the appropriate sample sizes and testing methodologies.

The data provenance is from non-clinical testing conducted by Better Care Plastic Technology Co., Ltd. located in Hebei Province, China. The data is prospective in the sense that these tests were conducted specifically to support this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the evaluation of these medical gloves relies on objective measurements performed according to recognized international standards (ASTM, ISO). There is no "ground truth" derived from expert consensus on medical images or clinical outcomes for this type of device. The "truth" is established by the standardized test methods themselves and the resulting physical and chemical measurements.

4. Adjudication method for the test set

This information is not applicable. The tests performed are objective, quantitative measurements according to predefined standards. There is no subjective assessment requiring adjudication.

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

This information is not applicable. This is a medical glove, a physical device, and not an AI-powered diagnostic or assistive technology for human readers.

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

This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for the performance of these gloves is based on objective measurements derived from standardized test methods (ASTM D6319-10, ASTM D6978-05, ISO 10993 series). For example:

• Physical properties (e.g., tensile strength, elongation): Measured directly by testing equipment following ASTM protocols.
• Freedom from holes: Determined by a standardized water-leak test (ASTM D5151-06).
• Chemotherapy drug permeation: Measured by detecting the breakthrough of chemotherapy drugs through the glove material over time, as per ASTM D6978-05.
• Biocompatibility: Evaluated using established in-vitro and in-vivo biological tests (cytotoxicity, irritation, sensitization) according to ISO 10993 standards.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of validating a medical glove. The product is manufactured and then tested to ensure it meets performance standards.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's a breakdown of the acceptance criteria and the study information for the Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), based on the provided text:

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 used for the individual tests (e.g., tensile strength, pinholes, biocompatibility, resistance to permeation). However, it indicates that the device's physical and performance characteristics meet the requirements of ASTM D 6319-10 and ASTM D 6978-05, which are standards that specify testing methodologies and, implicitly, sample sizes (e.g., AQL levels for pinholes).

The data provenance is from non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The country of origin for the device manufacturer is CHINA (Hebei Province). The testing itself (e.g., ASTM standards, ISO standards) is generally applicable internationally. The document does not specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be considered prospective in the sense that the device was specifically tested to demonstrate compliance for this submission.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM, ISO) that yield quantitative measurements (e.g., tensile strength values, breakthrough detection times, pass/fail for pinholes, irritation/sensitization ratings). There isn't a need for expert consensus in the way there would be for image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the acceptance criteria are based on objective measurements against established standards, not on subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, and the study aims to assess the impact of an AI tool on their performance. For a medical glove, performance is evaluated through physical, chemical, and biological testing as outlined above.

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

This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not an independent algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Standardized Test Results: Compliance with established industry standards such as ASTM D6319-10 (for physical properties like tensile strength, elongation, dimensions, freedom from holes, residual powder) and ISO 10993-10 (for biocompatibility).
• Quantitative Measurement: For chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time (BDT), determined according to ASTM D6978-05.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of the glove and its materials are designed to meet the specifications, and the testing ensures these specifications are met for production batches.

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

This is not applicable for the same reasons as #8.

Ask a specific question about this device