Search Results

The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Medical Examination Gloves (Nitrile) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in sizes extra-small, small, medium, large, extra-large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.

This request asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. However, the provided text is an FDA 510(k) clearance letter for Medical Examination Gloves (Nitrile). This type of device is a low-risk product and its clearance documentation does not involve AI-driven diagnostics, clinical trials, or the detailed study methodologies (like blinding, sample sizes for test/training sets, expert adjudication, MRMC studies) that would be present for a complex medical software device.

The information provided pertains to the physical and chemical properties of examination gloves, focusing on:

• Biocompatibility: Tests for irritation, sensitization, and acute systemic toxicity.
• Performance Testing (Physical): Dimensions, tensile strength, elongation, freedom from holes, and residual powder.

Therefore, many of the requested elements (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," etc.) are not applicable to the documentation for a medical glove.

I will interpret the request based on the actual content related to the medical gloves, explaining the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in that context.

Device: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Product Code: LZA
Regulation Number: 21 CFR 880.6250 - Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved

1. Table of Acceptance Criteria and the Reported Device Performance

The "study" in this context refers to non-clinical laboratory testing of the glove's physical, chemical, and biological properties.

Biocompatibility Testing:

Physical Performance Testing (against ASTM D6319-19 and other relevant standards):

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

• Sample Sizes:
  • Freedom from holes: 80 pieces per size were tested (total of 400 gloves for 5 sizes if all were tested equally). All 80 pieces passed for each size.
  • Other tests (Biocompatibility, Dimensions, Physical Properties, Residual Powder): Specific sample sizes are not explicitly stated in the provided text beyond "80 of 80 passed" for the holes test. However, these are standard laboratory tests typically performed on a representative sample set according to the respective ASTM/ISO standards.
• Data Provenance: The tests were non-clinical, laboratory-based. The location or "country of origin" of the testing itself is not explicitly stated, but the applicant (Humanwell Healthcare Group Medical Supplies Co., Ltd.) is based in Wuhan, Hubei Province, China. The testing would have been conducted to demonstrate compliance with international standards (ASTM, ISO) accepted by the FDA. The data is retrospective in the sense that it was collected prior to the 510(k) submission.

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

Not applicable. For medical gloves, "ground truth" is established by adherence to internationally recognized consensus standards (ASTM, ISO) for physical, chemical, and biological properties, not by human expert interpretation of images or other subjective assessments. The results are objective measurements from laboratory tests.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, quantitative measurements following defined protocols (e.g., ASTM D6319-19, ASTM D5151-19, ISO 10993 series). There is no "adjudication" in the sense of resolving inter-reader variability as there would be for an AI-powered diagnostic device.

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 medical examination glove, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, typically of imaging devices or AI algorithms.

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

Not applicable. This device is a medical examination glove, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on objective, verifiable measurements against established consensus standards (e.g., ASTM and ISO standards for physical properties, biocompatibility). It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. As this is not an AI algorithm, there is no training set or associated ground truth establishment process.

Ask a specific question about this device