(114 days)
Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test chemotherapy drug and concentration Minimum breakthrough detection time in minutes Bleomycin (15.0 mg/ml) >240 Busulfan (6.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Carmustine (3.3 mg/ml) 24.1 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Cytarabine HCl (100.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Daunorubicin HCl (5.0 mg/ml) >240 Docetaxel (10.0 mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Epirubicin (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fludarabine (25.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Gemcitabine (38.0 mg/ml) >240 Idarubicin (1.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Irinotecan (20.0 mg/ml) >240 Mechlorethamine HCI (1.0 mg/ml) >240 Melphalan (5.0mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0mg/ml) >240 Oxaliplatin (2.0 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Rituximab (10.0 mg/ml) >240 ThioTEPA (10.0 mg/ml) 26.0 Vincristine Sulfate (1.0 mg/ml) >240 Warning: Do not use with Carmustine or ThioTEPA
Gammex PI Hybrid Micro Surgical Gloves are sterile and disposable devices. The gloves are made of a synthetic rubber polyisoprene and neoprene blend. Ansell has performed independent laboratory testing to support use with Chemotherapy Drugs and Non-Pyrogenic claims. The glove has a shelf life of 3 years, is brown in color and comes in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Each size is assigned with a model number.
The document provides information on the non-clinical testing conducted for the GAMMEX PI Hybrid Micro surgical gloves. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions (ASTM D3767-03) | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves. | PASS |
| Physical Properties (ASTM D3577-19) | Acceptance criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19. | PASS |
| Freedom from holes (ASTM D5151-19) | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 1.5. | PASS |
| Powder-Free (ASTM D6124) | Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19. | PASS |
| Sterility (ANSI/AAMI/ISO 11137-1:2006) | Meets acceptance criteria requirement of 10-6 SAL per ISO 11137-1: Sterilization for Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of A Sterilization Process For Medical Devices. | PASS |
| Chemotherapy Drug Permeation Test (ASTM D6978-05(2019)) | Acceptance Criteria in accordance with ASTM D6978-05(2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. (Specific breakthrough times for each drug are listed in the "Indications for Use" section). | PASS (with specific breakthrough times. Noted that Carmustine (24.1 min) and Thiotepa (26.0 min) have extremely low permeation times, leading to a warning for these drugs.) |
| ISO in vitro Cytotoxicity (ISO 10993-5) | Acceptance criteria in accordance with ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity, 2009. | FAIL (Surfaces at undiluted were found to be cytotoxic (grade 4) to L-929 cells and non-cytotoxic with grade 0 at 1:2, 1:4, 1:8, 1:16, 1:32 and 1;64 dilutions.) |
| ISO Skin Irritation Study (ISO 10993-10:2010) | Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation Of Medical Devices, Part 10: Test for Irritation and Skin Sensitization. Under the conditions of the study, not an irritant. | PASS |
| ISO Maximization Sensitization Study (ISO 10993-10:2010) | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for Irritation and Skin Sensitization. Under the conditions of the study, not a sensitizer. | PASS |
| ISO Acute Systemic Toxicity Study (ISO 10993-11:2017) | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for Systemic Toxicity. Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity. | PASS |
| Material Mediated Pyrogenicity Study (USP ) | Passes Material Mediated Pyrogenicity Test per USP . Under the conditions of the study, non-pyrogenic. | PASS |
| Endotoxin Study | Less than 20.0 EU/device. | PASS |
Note regarding Cytotoxicity: Although the in vitro cytotoxicity test showed a "FAIL" at undiluted concentrations, the document states that the extracts were then evaluated by ISO 10993-11 for systemic toxicity, which passed, indicating no systemic response in the animal model. This suggests a different acceptance pathway for cytotoxicity, likely due to further evaluation in an in vivo model.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific sample sizes for each non-clinical test.
- The data provenance is from non-clinical tests performed by Ansell Healthcare at independent laboratories. There is no information regarding country of origin, but it is implied to be laboratory-based testing rather than human subject data. The studies are by nature prospective as they are conducted for the purpose of demonstrating safety and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. These are non-clinical tests based on standardized laboratory methods (e.g., ASTM, ISO, USP), not interpretation by human experts. The "ground truth" is defined by the objective measurement criteria of these standards.
4. Adjudication method for the test set:
- This information is not applicable, as the tests are objective measurements according to standardized protocols, not subjective assessments requiring expert 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:
- This information is not applicable. The device is a surgical glove, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable. The device is a physical product (surgical glove), not an algorithm or software.
7. The type of ground truth used:
- The ground truth used for these tests is based on established international and national standards and methodologies (e.g., ASTM, ISO, USP) for evaluating the physical, chemical, and biological properties of medical devices like surgical gloves. These standards define the objective criteria and test methods to determine acceptable performance.
8. The sample size for the training set:
- This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable, as it's not a machine learning driven device.
§ 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).