(59 days)
The Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
The Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
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This document describes the FDA's 510(k) premarket notification for Polyisoprene Powder Free Surgical Undergloves and Surgical Gloves for Use with Chemotherapy Drugs. The study focuses on the gloves' resistance to permeation by chemotherapy drugs, as opposed to an AI/algorithm-based study. Therefore, typical AI/ML study components like MRMC, training sets, and expert consensus for ground truth are not applicable.
Here's an analysis of the provided text in relation to your request, focusing on the appropriate acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for these gloves are defined by their resistance to permeation by various chemotherapy drugs, measured by "Minimum Breakthrough Detection Time in Minutes" as per ASTM D6978-05 (Reapproved 2019). While the document doesn't explicitly state quantitative acceptance thresholds for each drug (e.g., "must be greater than X minutes"), the reported performance is the data by which acceptance is demonstrated. The implication is that the breakthrough times must be sufficiently high to offer protection, and the "Note" highlighting low times for Carmustine and Thiotepa indicates they are acknowledging these specific drugs are exceptions with shorter protection times.
Therefore, the table below lists the performance, which serves as the fulfillment of the "acceptance criteria" for demonstrating drug permeation resistance.
Table of Reported Device Performance against Chemotherapy Drugs
| Chemotherapy Drug and Concentration | Polyisoprene Powder Free Surgical Underglove (Blue) - Minimum Breakthrough Detection Time in Minutes | Polyisoprene Powder Free Surgical Glove (Natural) - Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (3.3 mg/ml) | 13.4 | 14.5 |
| Cisplatin (1.0 mg/ml) | >240 | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 | >240 |
| Dacarbazine (10.0 mg/ml) | >240 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 |
| Etoposide (20.0 mg/ml) | >240 | >240 |
| Fluorouracil (50.0 mg/ml) | >240 | >240 |
| Methotrexate (25.0 mg/ml) | >240 | >240 |
| Mitomycin C (0.5 mg/ml) | >240 | >240 |
| Paclitaxel (6.0 mg/ml) | >240 | >240 |
| Thiotepa (10.0 mg/ml) | 15.2 | 23.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 | >240 |
Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively." (This note appears the same for both glove types, although for the "Natural" glove, Thiotepa is 23.5 minutes, so the specific wording might be a copy-paste error in the original document, but the point is these are recognized as lower performance points). This serves as a critical piece of information for users to be aware of the limited protection time for these specific drugs.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of gloves tested) for the permeation tests. It only lists the results.
The data provenance is implied to be from Hartalega SDN. BHD., located in Malaysia, as they are the submitter of the 510(k). The tests are based on an industry standard (ASTM D6978-05), which implies a standardized, retrospective testing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" is established by the physical and chemical properties of the gloves and their interaction with the specified chemotherapy drugs, measured according to a standard laboratory protocol (ASTM D6978-05). It does not involve human expert interpretation of images or other subjective data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a laboratory-based objective measurement of material properties, not an interpretative study 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 device is a surgical glove, not an AI/ML-driven diagnostic or assistive tool. There are no "human readers" in this context, nor any AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm; it's a physical product assessed for its barrier properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is established by standardized laboratory testing and measurement based on direct observation of breakthrough time using the ASTM D6978-05 (Reapproved 2019) protocol. This is an objective, quantitative measurement of material performance.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. Since there's no training set for an AI/ML model, there's no ground truth established for it.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).