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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The qloves are offered in four sizes: extra-small, small, medium, large, and extra-large.

This document describes the premarket notification (510(k)) for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs). The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K190860). The "device" in this context refers to the Nitrile Examination Gloves. The acceptance criteria and the study that proves the device meets them are based on non-clinical (bench) testing, as no clinical testing was performed or required for this device type.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally defined by compliance with specific ASTM and ISO standards, and the reported performance are the test results demonstrating this compliance.

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

• Sample Size for Test Set:
  • Freedom from Holes (ASTM D5151-19): 125 gloves.
  • Chemotherapy Drug Permeation (ASTM D6978-05): The table provides individual breakthrough detection times for some drugs, indicating multiple samples were tested (e.g., three reported times for Carmustine and Thio Tepa). Specific sample sizes for each drug are not explicitly stated beyond these examples.
  • Other tests (Biocompatibility, Physical Properties, Residual Powder): Specific sample sizes are not detailed in the provided text, but testing was conducted "in accordance with" the listed standards, implying standard-appropriate sample sizes were used.
• Data Provenance: This is a 510(k) submission for a medical device (nitrile examination gloves). The testing is non-clinical (bench testing), meaning it was performed in a laboratory setting to assess the physical and chemical properties of the gloves. The country of origin of the data is not explicitly stated for each test, but the submitting company is 5R MED Instruments (CHENGDU) Co., Ltd. located in China. The testing would have been conducted in a controlled lab environment. The studies are prospective tests performed on the manufactured device to ensure it meets the required standards.

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

Not applicable. For a device like examination gloves, "ground truth" is established by laboratory measurements against defined standards (e.g., strength, thickness, permeation time), not by expert human interpretation of medical images or clinical outcomes. The tests are objective, quantifiable measurements.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (like medical images) and their discrepancies need to be resolved. For non-clinical bench testing, the results are quantitative and directly measured by calibrated equipment and documented procedures.

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

No. MRMC studies are used to evaluate the diagnostic performance of medical imaging devices, often comparing human readers with and without AI assistance. This submission is for examination gloves, which do not involve such diagnostic tasks.

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

Not applicable. "Standalone performance" typically refers to the performance of an AI algorithm without human involvement. This device is not an AI algorithm. Its performance is demonstrated through physical and chemical property testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is objective, measurable physical properties and chemical resistance, defined by international standards:

• Standard-defined thresholds: For properties like tensile strength, elongation, freedom from holes (AQL), residual powder, dimensions (length, width, thickness), and breakthrough times for chemotherapy drugs.
• Laboratory measurements: Results obtained from standardized test methods (ASTM, ISO).
• Biocompatibility assessments: Based on established criteria for irritation, sensitization, and cytotoxicity from biological assays.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML model. There is no "training set" in the context of examination gloves.

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it. The ground truth for the device's performance is based on its physical, chemical, and biological properties measured against established standards during non-clinical testing.

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The Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

This is a 510(k) premarket notification for Nitrile Examination Gloves, a Class I reserved medical device. The submission aims to demonstrate substantial equivalence to a predicate device (K171422). The "acceptance criteria" in this context refers to the performance standards and test results that the new device must meet to be considered substantially equivalent to the predicate device and safe/effective for its intended use.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The provided tables (Table2 Device Dimensions Comparison, Table3 Performance Comparison, and Table4 Safety Comparison) effectively serve as a comparison of the proposed device's performance against the predicate device, which inherently defines the "acceptance criteria" for substantial equivalence.

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

• Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for Freedom from Holes, Tensile Strength, etc.). It only references compliance with ASTM standards, which would define appropriate sample sizes for those tests.
• Data Provenance: The tests are non-clinical (laboratory tests). The manufacturing location is China (5R MED Instruments (Chengdu) Co., Ltd.). The tests themselves are performed according to international (ISO) and U.S. (ASTM) standards. These are prospective tests, specifically conducted to demonstrate compliance for this device submission.

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

This device is not an AI/software device that requires human expert adjudication for ground truth. The "ground truth" for Nitrile Examination Gloves is established by objective, standardized physical and chemical tests defined by international (ISO) and U.S. (ASTM) consensus standards. Therefore, human experts for ground truth establishment in the clinical sense are not applicable here. The experts involved would be the certified laboratory technicians and engineers performing and interpreting the results of the specified standards.

4. Adjudication method for the test set:

Not applicable. As noted above, this device relies on objective, quantifiable physical and chemical tests, not subjective interpretations 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:

Not applicable. This is a physical medical device (gloves), not an AI-powered diagnostic or assistance tool.

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

Not applicable. This is a physical medical device (gloves).

7. The type of ground truth used:

The ground truth is established by objective, standardized tests defined by ASTM and ISO standards. These standards provide quantifiable criteria for properties like dimensions, tensile strength, elongation, freedom from holes, powder content, and biocompatibility.

8. The sample size for the training set:

Not applicable. This is a physical medical device, 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 above, no training set is involved for this type of device.

In summary, the "study" proving the device meets acceptance criteria consists of a series of non-clinical, laboratory-based tests conducted in accordance with recognized industry standards (ASTM D6124, ASTM D5151, ASTM D6319, ASTM D7160, ISO 10993-10, ISO 10993-5). The acceptance criteria are essentially the performance requirements set forth in these standards and demonstrated by the predicate device. The results of these tests (summarized in the tables) indicate that the proposed device performs comparably to the predicate and meets the relevant safety and performance standards.

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