(298 days)
The 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.
SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color is to function in the same manner as various other surgical gloves existing in industry today. The proposed SensiCare surgical glove is a disposable 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. It has limited contact duration (
This document is a 510(k) premarket notification for a medical device: "SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color".
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard (Test Set) | Reported Device Performance |
|---|---|
| Freedom from Holes: | |
| ASTM D3577-09e | Meets ASTM D3577-09e |
| ASTM D5151-06 | Meets ASTM D5151-06 |
| Residual Powder: | |
| ASTM D6124-06 & definition for Powder-Free (≤2 mg/glove) | Meets ASTM D6124-06 & definition for Powder-Free; ≤2 mg/glove |
| Primary Irritation: | |
| ISO 10993-10 (No Dermal Irritation Potential) | Meets ISO 10993-10; No Dermal Irritation Potential |
| Dermal Sensitization: | |
| ISO 10993-10 (No Sensitization Potential) | Meets ISO 10993-10; No Sensitization Potential |
| Performance (e.g., Physical Properties): | |
| ASTM D3577-09e | Meets ASTM D3577-09e |
| Chemotherapy Drug Permeation (Breakthrough Detection Time - ASTM D6978-05): | Meets ASTM D6978-05. Specific times listed below: |
| Carmustine | Avg. 15.7 minutes (15.7, 16.3, 17.0) |
| Cisplatin | 240 minutes |
| Cyclophosphamide (Cytoxan) | 240 minutes |
| Dacarbazine (DTIC) | 240 minutes |
| Doxorubicin Hydrochloride | 240 minutes |
| Etoposide (Toposar) | 240 minutes |
| Fluorouracil | 240 minutes |
| Ifosfamide | 240 minutes |
| Methotrexate | 240 minutes |
| Mitomycin C | 240 minutes |
| Paclitaxel (Taxol) | 240 minutes |
| Thiotepa | Avg. 15.3 minutes (15.3, 15.3, 15.3) |
| Vincristine Sulfate | 240 minutes |
| Dimensions & Tolerances: | |
| ASTM D3577-09e | Meets ASTM D3577-09e |
| FDA Medical Glove Guidance Manual | Meets FDA Medical Glove Guidance Manual |
Note: The document explicitly states a "WARNING: Do not use with Carmustine and Thiotepa" despite reporting permeation times, indicating these times are likely too short for safe use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for holes, powder, or chemotherapy permeation). It references standards like ASTM D3577-09e, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05, which would define the required sample sizes for such tests.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are non-clinical (laboratory-based performance testing of the device itself) and would have been conducted by the manufacturer or a contracted testing facility to demonstrate compliance with the referenced standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for these device performance tests is established by objective, standardized measurements and adherence to specified test methods within the ASTM and ISO standards, rather than expert consensus on interpretation. For example, breakthrough detection time for chemotherapy drugs is a direct measurement, and a glove either passes or fails based on the objective criteria of the standard.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective performance tests with defined pass/fail criteria from international and national standards (ASTM, ISO). There is no "adjudication" in the sense of reconciling subjective expert opinions.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. This document describes the non-clinical performance testing of a surgical glove, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not relevant or applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device (surgical glove), not a software algorithm. Therefore, "standalone algorithm-only performance" is not relevant.
7. Type of Ground Truth Used
The ground truth used for these tests is based on objective, standardized measurements and compliance with established performance criteria defined in international and national standards (ASTM D3577-09e, ASTM D5151-06, ASTM D6124-06, ASTM D6978-05, ISO 10993-10). These are quantifiable metrics (e.g., length, width, thickness, freedom from holes, residual powder, breakthrough detection time, biological response like irritation/sensitization).
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical glove), not a machine learning model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as 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).