(233 days)
This surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
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This document is an FDA 510(k) Premarket Notification for a surgical glove, not an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study design for AI evaluation (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details), and adjudication methods is not applicable to this document.
The document describes the performance of the SensiCare PI Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera, specifically its resistance to chemotherapy drug permeation.
Here's how the provided information relates to the "device" (the surgical glove) under review:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for these gloves, as relevant to the provided data, would implicitly be that the breakthrough detection time (permeation time) for chemotherapy drugs should be sufficiently long to provide protection, ideally exceeding 240 minutes for most drugs. The device performance is reported directly in the tables on pages 3 and 5.
Acceptance Criteria & Reported Performance for SensiCare PI Sterile Surgical Gloves (Natural and Green Colors)
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implied) | Reported Performance (Breakthrough Detection Time in Minutes) - Natural Color (Page 3) | Reported Performance (Breakthrough Detection Time in Minutes) - Green Color (Page 5) |
|---|---|---|---|---|
| Bleomycin | 15 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Busulfan | 6 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Carboplatin | 10.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml | Longer time preferred | 22.5 (23.4, 23.8, 22.5) minutes | 13.7 (14.4, 14.4, 13.7) minutes |
| Cisplatin | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Epirubicin (Ellence) | 2 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Fludarabine | 25.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Idarubicin | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Ifosfamide | 50.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Mechlorethamine HCI | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Melphalan | 5 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Methotrexate | 25 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Mitomycin C | 0.5 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Mitoxantrone | 2.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Paraplatin | 10 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Rituximab | 10 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Thiotepa | 10.0 mg/ml | Longer time preferred | 24.4 (25.3, 24.4, 25.6) minutes | 13.8 (13.8, 16.4, 14.8) minutes |
| Vincristine Sulfate | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
Warning: The document explicitly states "Warning: Do not use with Carmustine and Thiotepa" for both glove types due to their limited breakthrough times.
The remaining points (2-9) are not applicable as this is not an AI/software device:
- Sample sized used for the test set and the data provenance: Not an AI study. This relates to physical testing of gloves for chemical permeation. The standard for such testing would typically involve multiple glove samples to ensure reproducibility and statistical validity, but the specific sample size for each drug test is not provided in this regulatory letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established through laboratory testing, not expert consensus (e.g., using analytical chemistry methods to detect drug breakthrough).
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for evaluating changes in human reader performance with AI.
- If a standalone was done: Not applicable. This refers to algorithm-only performance.
- The type of ground truth used: For these gloves, the "ground truth" is the measured breakthrough time of the chemotherapy drugs through the glove material, determined by standardized laboratory methods (e.g., ASTM F739 or similar).
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory letter for a medical device (surgical gloves) and details its performance against specific chemical permeation, which are the relevant "acceptance criteria" and "study results" for this type of product. The questions posed are designed for AI-driven medical devices and thus, are largely not relevant to this document.
§ 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).