(164 days)
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient. These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
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The provided document describes the FDA's 510(k) clearance for "Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs" and "Sterile Latex Surgical Powder Free Gloves". The primary "acceptance criteria" and "study" described pertain specifically to the chemotherapy drug permeation resistance of the Nitrile gloves.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance (for Nitrile Gloves):
| Chemotherapy Drug | Concentration | Acceptance Criteria (Breakthrough Detection Time - Minutes) | Reported Device Performance (Breakthrough Detection Time - Minutes) |
|---|---|---|---|
| Carmustin (BCNU) | 3.3mg/ml | Not explicitly stated, but practical minimum for safe use. | 8.0 |
| Cisplatin | 1.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Etoposide (Toposar) | 20.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Fluorouracil | 50.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Thiotepa | 10.0mg/ml | Not explicitly stated, but practical minimum for safe use. | 16.2 |
Note: The document states "Please note that the following drugs have extremely low permeation times: Carmustin (BCNU) : 8.0 minutes and Thiotepa : 16.2 minutes." This implies that while the gloves offer some protection, these specific drugs have a limited breakthrough time, which would practically serve as an informal "acceptance criterion" for healthcare professionals to consider when using these gloves with those drugs. The formal acceptance criteria for breakthrough time are typically defined by a standard, but the specific numerical threshold for "acceptable" is not explicitly listed in this document beyond the measured values. The study performed adheres to the ASTM D6978-05 standard, which defines the methodology. It's implied that exceeding the 240-minute mark is generally considered excellent performance for chemotherapy drug resistance.
2. Sample size used for the test set and the data provenance:
- The document states the gloves were "tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs."
- Sample Size: The exact sample size (number of gloves tested per drug) is not specified in this document. The ASTM D6978-05 standard typically dictates the sample size and methodology.
- Data Provenance: This information is not explicitly stated in the provided document (e.g., country of origin, retrospective or prospective). It is likely from the manufacturer's internal testing as part of their 510(k) submission. Given it's a submission to the FDA, the testing was likely prospective for the purpose of demonstrating compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of device and study. The testing for chemotherapy drug permeation is a physical/chemical test performed in a laboratory setting, not an assessment requiring expert consensus on images or clinical outcomes. The "ground truth" is established by the direct measurement of drug permeation according to a standardized method (ASTM D6978-05).
4. Adjudication method for the test set:
- Not applicable. As noted above, this is a laboratory-based permeation test, not a clinical assessment requiring adjudication among multiple readers.
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-assisted diagnostic or therapeutic device. Therefore, MRMC studies involving human readers and AI are irrelevant to its evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (gloves), not an algorithm or software.
7. The type of ground truth used:
- The ground truth is established by direct physical/chemical measurement of chemotherapy drug permeation through the glove material using a standardized test method (ASTM D6978-05). This involves quantitative analysis to detect and measure the breakthrough time of the specific drugs.
8. The sample size for the training set:
- Not applicable. This device is a physical product. There is no concept of a "training set" in the context of its evaluation for chemotherapy drug permeation.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).