(152 days)
A powder-free 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.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Nitrile Medical Examination Glove is a non-sterile, single-use, disposable glove intended for medical purposes to be worn on the hands of examiners to prevent contamination between an examiner and the patient. The gloves are made of nitrile butadiene rubber and are white-colored and powder-free. The gloves are offered in one version in a range of sizes: x-small, small, medium, large, and x-large.
The provided text describes the acceptance criteria and performance testing for a Nitrile Patient Examination Glove, specifically regarding its resistance to chemotherapy drugs and Fentanyl Citrate, as well as general safety and physical properties. It does not describe an AI medical device, therefore, many of the requested fields are not applicable.
Here's the breakdown based on the provided text:
Key Takeaway: This document is a 510(k) submission for a medical glove, demonstrating substantial equivalence to a predicate device, primarily through performance testing against established ASTM and ISO standards for physical properties, biocompatibility, and chemical permeation. It does not involve an AI algorithm or human-in-the-loop studies.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-10 | Irritation | Not a skin irritant | The subject device is non-irritating |
| ISO 10993-10 | Skin Sensitivity | Not a skin sensitizer | The subject device is non-sensitizing |
| ISO 10993-5 | Cytotoxicity | No cytotoxic reactivity | Failed (Exhibits severe cytotoxicity reactivity at 100%) |
| ISO 10993-11 | Acute Systemic Toxicity | No systemic reactivity | Pass (No systemic toxicity concern) |
| ASTM D6978 | Permeation of Chemotherapy Drugs | ≥240 minutes breakthrough time (for most drugs) | Pass (>240 minutes for most drugs, 33.3 for Carmustine, 66.2 for Thiotepa) |
| ASTM D6978 | Permeation of Fentanyl | ≥240 minutes breakthrough time | Pass (>240 minutes) |
| ASTM D6124 | Powder Residue | 2 mg/glove maximum | Pass |
| ASTM D5151 | Pinhole Test | Free from holes, AQL 1.5 | Pass |
| ASTM D6319 | Physical Properties (Before aging) | Tensile strength: Min. 14 MPa; Elongation: Min. 500% | Pass |
| ASTM D6319 | Physical Properties (After aging) | Tensile strength: Min. 14 MPa; Elongation: Min. 400% | Pass |
| Specific Chemotherapy Drugs | Minimum Breakthrough Detection Time (Minutes) (for those =240 minutes" might be an overall expectation, these specific drugs fall below that, but are disclosed with warnings, indicating that the device still "passes" within the context of defined usage and limitations.* |
2. Sample sizes used for the test set and the data provenance
The document describes material testing, not a dataset in the typical sense for AI. No specific "sample sizes" for a "test set" of patient data are applicable or mentioned. The testing is performed on samples of the manufactured gloves themselves according to standard test methods (ASTM, ISO).
- Data Provenance: Not applicable. These are laboratory test results from the manufacturer's product, not patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical glove, and its performance is evaluated against physical and chemical permeation standards (ASTM, ISO), not expert interpretation of medical images or clinical data. There is no concept of "ground truth" established by experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiology reads). This involves objective laboratory testing against pre-defined physical and chemical resistance criteria.
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 not an AI device or a diagnostic device involving human readers or interpretation of medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the validated and established laboratory test methods and standards (ASTM D6978, ISO 10993, etc.). For example:
- Permeation of chemotherapy drugs: Measured breakthrough time.
- Physical properties: Measured tensile strength, elongation.
- Biocompatibility: Measured biological reactions (irritation, sensitization, cytotoxicity, systemic toxicity) in accordance with ISO standards.
8. The sample size for the training set
Not applicable. This is a medical glove, not an AI model. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set for an AI model, there is no ground truth establishment for it.
§ 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.