(140 days)
The Disposable Medical Nitrile Examination Glove is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study conducted for a medical device: "Disposable Medical Nitrile Examination Gloves (non-sterile)." This is a Class I medical device, and the study focused on non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than the types of studies typically performed for AI/ML-based diagnostic devices. Therefore, many of the requested categories are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5 Biological evaluation of medical devices Test for in vitro cytotoxicity | To determine the potential cytotoxicity. | Non-cytotoxic | Pass |
| ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for Systemic Toxicity | To determine the potential systemic toxicity. | Does not cause systemic toxicity. | Pass |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test for Irritation and Skin Irritation | To determine the potential for irritation and skin irritation. | Non-irritant, and Non skin irritant. | Pass |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test Skin Sensitization | To determine the potential skin sensitization. | Does not cause skin sensitization. | Pass |
| ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application | To test for: (1) freedom from holes (2) physical dimensions (3) Aging | (1) Shall not leak (2) For size L (mm): Width: 110 ± 10, Length: ≥ 230, Finger and palm thickness: median value ≥ 0.05 (3) After Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: ≥400% | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an AI/ML device. The tests performed are for medical gloves and involve physical and biological property assessments, not analysis of data from patients or images. The provenance of the samples (e.g., country of origin for the gloves tested) is not specified beyond the manufacturer's location (China). These were non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the physical and biological properties of the gloves is established by standardized testing protocols (ISO, ASTM) and measurements, not by expert interpretation of data relevant to AI/ML.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, the tests are for physical and biological properties of gloves, not for AI/ML performance requiring adjudication of interpretations.
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 glove, not an AI-based diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is based on objective measurements and established standards for material properties (e.g., tensile strength, elongation), dimensional specifications (e.g., length, width, thickness), and biocompatibility assays (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.