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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

*WARNING: Do not use Carmustine and ThioTepa.

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This document is a 510(k) premarket notification for a medical device, specifically Powder Free Nitrile Surgical Glove, Sterile, Tested For Use With Chemotherapy Drugs. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested details about acceptance criteria, test sets, experts, and ground truth are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a surgical glove.

However, based on the provided text, we can extract information regarding the device's performance against specific standards:

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

The acceptance criteria here are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is presented in the table provided in the "Indications for Use" section. For most drugs, the performance exceeds 240 minutes, with the notable exception of Carmustine and ThioTepa.

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 does not specify the sample size for the testing of the chemotherapy drug permeation. It is a standard test defined by ASTM D6978, which would outline the appropriate sample size. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. This testing is typically prospective, performed on newly manufactured batches of gloves.

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 question is not applicable. The "ground truth" here is the measured breakthrough time of chemotherapy drugs through the glove material, determined by laboratory testing according to ASTM D6978. It does not involve expert medical opinion or consensus.

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

This question is not applicable. Adjudication methods are typically used when human judgment is involved in establishing a ground truth, such as in clinical studies with expert readers. Here, the "truth" is an objective measurement from a standardized test.

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 question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve an algorithm.

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

The ground truth used is objective measurement based on a standardized laboratory test (ASTM D6978). The breakthrough detection time is a direct measurement of how long it takes for a chemotherapy drug to permeate through the glove material.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of testing the performance of a physical device like a surgical glove against a standardized permeation test.

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

This question is not applicable, as there is no training set mentioned in this context.

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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
Carmustine (BCNU) 3.3mg/ml 30.4
Cisplatin 1.0mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Dacarbazine 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Thiotepa 10.0mg/ml 59.0
Vincristine Sulfate 1.0mg/ml > 240

CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.

Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.

The powder free nitrile surgical glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.

This document describes the acceptance criteria and performance study for the Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823).

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against ASTM standards for various characteristics and against the ASTM D6978-05 standard for chemotherapy drug permeation.

Note regarding Chemotherapy Drug Permeation: For Carmustine and Thiotepa, a "CAUTION" statement is included, indicating average breakthrough times of 30.4 minutes and 59.0 minutes, respectively. This implies that while the glove offers some protection, it is not indefinitely resistant to these specific drugs, and users should be aware of these breakthrough times. The other listed drugs showed breakthrough times greater than 240 minutes, indicating high resistance under the tested conditions.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for watertightness, number of samples for chemotherapy permeation). However, it indicates adherence to relevant ASTM standards (D3577-09, D6978-05, D5151-06, D6124-06) and ISO standards (ISO 10993-10), which would dictate appropriate sample sizes for these types of tests.

The data provenance is not explicitly stated in terms of country of origin for the testing, but the submitter is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing adheres to international and US standards (ASTM, ISO, 21 CFR), suggesting a globally recognized testing methodology. The studies are non-clinical performance tests.

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

This information is not applicable as the ground truth for medical gloves is established through objective physical, chemical, and biological testing against established international and national standards (ASTM, ISO, FDA regulations). There is no mention of human expert assessment or consensus being used to establish a "ground truth" for the device's performance characteristics in the way it might be for diagnostic AI.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements and compliance with predefined standards, not on human interpretation or adjudication of subjective data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes the testing of a medical device (surgical glove) based on its physical properties and resistance to chemicals, which does not involve human readers interpreting data alongside an AI.

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 (surgical glove), not an AI algorithm. Its performance is measured directly through laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Performance against established standards: This includes physical property measurements (tensile strength, elongation, dimensions), impermeability (watertightness), chemical resistance (chemotherapy drug permeation), cleanliness (powder-free), and biocompatibility (skin irritation, sensitization) as defined by ASTM and ISO standards and FDA regulations.
• The metrics are objective and quantitatively measured (e.g., length in mm, breakthrough time in minutes, mg/glove for powder, MPa for tensile strength).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is likely subject to quality control and statistical process control, which involves ongoing testing and process adjustments, but this is distinct from an AI training set.

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

This is not applicable for the reason stated in point 8.

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