(89 days)
Based upon 21CFR§880.6250 "Patient examination glove" Use: A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Light gray nitrile, chlorinated, powder-free, textured fingertip, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application
The provided text describes the acceptance criteria and the study conducted for the Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim. This information is from a Traditional 510(k) summary filed with the FDA.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Test | Standard | Acceptance Criteria / Reported Performance |
|---|---|---|
| Non-Clinical Tests | ||
| Dimensions | ASTM D 6319-00a | Meets |
| Physical Properties | ASTM D 6319-00a | Meets |
| Freedom from pinholes | ASTM D 6319-00a | |
| ASTM D 5151-06 | Meets | |
| Powder Free | ASTM D 6124-06 | |
| ASTM D 6319-00a | Meets | |
| ISO Skin Irritation Study | ISO 10993, Part 10 | Meets |
| Murine Local Lymph Node Assay | ISO 10993, Part 10 | Meets |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | Meets |
| Resistance to Permeation (Protective Clothing) | ASTM F 739-07 | See data below (specific breakthrough times reported for various chemotherapy drugs) |
| Resistance to Permeation (Medical Gloves) | ASTM D 6978-05 | See data below (specific breakthrough times reported for various chemotherapy drugs) |
| Chemotherapy Drug Permeation (Average Breakthrough Detection Time in minutes) | ||
| Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| Doxorubicin HCI (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| Paclitaxel (Taxol) (6.0 mg/ml) | No breakthrough up to 240 minutes | |
| ThioTEPA (10.0 mg/ml) | Avg. minutes before breakthrough = 54.2 | |
| Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes | |
| Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes | |
| Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes |
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 explicitly state the sample sizes for each of the specific non-clinical tests (e.g., number of gloves tested for pinholes, dimensions, or physical properties). For the chemotherapy drug permeation tests, it lists "Average Breakthrough Detection Time," implying multiple tests were conducted for each drug, but the exact number of samples for each is not specified.
The data provenance is not mentioned (e.g., country of origin). The testing would be considered prospective in the sense that the tests were conducted specifically to demonstrate compliance for this 510(k) submission.
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 product is a medical glove, not an AI/imaging device requiring expert consensus for ground truth. The "ground truth" for the device's performance is established by the standardized test methods themselves and the quantitative results obtained from those tests. Therefore, experts in establishing "ground truth" in the context of diagnostic interpretation are not applicable here. The experts involved would be those qualified to execute the specific ASTM and ISO standards for glove testing and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., in diagnostic imaging or clinical trials) where disagreements in judgment need to be resolved to establish ground truth. For this type of product and testing, the results are objectively measured per the specified standards.
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-assisted diagnostic or interpretation device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove, not an algorithm. The "standalone performance" is essentially the results of the physical and chemical tests conducted on the glove itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these gloves is based on:
- Standardized Test Methods: Adherence to established and recognized industry standards like ASTM D 6319-00a, ASTM D 5151-06, ASTM D 6124-06, ASTM F 739-07, ASTM D 6978-05.
- Biocompatibility Standards: Compliance with ISO 10993 (Parts 10 and 11) for skin irritation, sensitization, and systemic toxicity.
- Quantitative Measurements: Direct measurements of physical properties (dimensions, tensile strength, elasticity), freedom from defects (pinholes), powder content, and breakthrough times for specific chemotherapy drugs.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this device does not use a training set, the establishment of ground truth for such a set is irrelevant.
§ 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.