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510(k) Data Aggregation
(197 days)
HARPS Europe Manufacturing GmbH
The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
The tested drugs are:
| Compound | Minimum Breakthrough Time (minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Chloroquine (50 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Epirubicin HCl (2 mg/ml) | >240 |
| Fludarabine Phosphate (25 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Topotecan HCl (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes.
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a sterile and disposable device. This glove is made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. The device is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. These gloves were tested for use with Chemotherapy Drugs and Gastric Acid as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The device conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006 + AMD1:2013 + AMD2:2018, ISO 11137-2:2013 + AMD1:2022, and ASTM D6978-05.
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0.
The provided document is a 510(k) clearance letter from the FDA for a medical device: "Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid." This document outlines the general requirements for the device and details the non-clinical testing performed to establish substantial equivalence to a predicate device.
However, it does not contain any information regarding clinical studies, AI/ML device performance, or human-in-the-loop studies. The device is a physical medical glove and not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements related to AI/ML and clinical study methodologies are not applicable to this submission.
The document focuses on demonstrating the physical, chemical, and biological safety and performance of the gloves according to recognized consensus standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent non-clinical testing against several recognized standards. The "Results" column consistently states "PASS," indicating that the device met the specified acceptance criteria for each test.
| Title of Test | Purpose of Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D3577-19 | Dimensions | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ASTM D3577-19 | Physical Properties | Meets criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ASTM D5151-19 | Freedom from holes | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 0.65 | PASS |
| ASTM D6124 | Powder-Free | Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ISO 11137-1:2006 | Sterility | 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 |
| ASTM D6978-05 | Chemotherapy Drug Permeation Test | Testing performed in accordance with ASTM D6978-05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | PASS |
| ISO 10993-10:2010 | Biocompatibility: Skin Irritation | 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 10993-10:2010 | Biocompatibility: Dermal Sensitization | 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 10993-11:2017 | Biocompatibility: Acute Systemic Toxicity | 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 |
| ISO 10993-11:2017 | Biocompatibility: Material-Mediated Pyrogenicity | Passes Material-Mediated Pyrogenicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, no pyrogenic response was observed. | PASS |
| USP | Endotoxin Testing | Meets acceptance criteria for bacterial endotoxins per USP Bacterial Endotoxins Test. Endotoxin level ≤ 20 EU/device. | PASS |
Chemotherapy Drug Permeation Results:
| Compound | Minimum Breakthrough Time (minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Chloroquine (50 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Epirubicin HCl (2 mg/ml) | >240 |
| Fludarabine Phosphate (25 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Topotecan HCl (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
| Stomach Acid | >240 |
Warning: Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.
Summary of Study Information (Not Applicable for this Device Type)
The provided document describes a Class I medical device (Sterile Powder Free Synthetic Rubber Surgeon's Gloves) which is a physical product, not a software device or an AI/ML-driven system. Therefore, the following requested information points related to AI/ML device performance and clinical study methodologies are not applicable. The submission primarily relied on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device tested via non-clinical laboratory methods according to recognized standards (e.g., ASTM, ISO). The specific sample sizes for each non-clinical test (e.g., number of gloves for tensile strength, number of samples for permeation, number of animals for biocompatibility) are part of the detailed test reports but are not summarized in this FDA summary document. Data provenance details like country of origin for test materials or retrospective/prospective nature are not specified as they are not relevant for this type of non-clinical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices interpreting medical images or other complex data. For gloves, "ground truth" is established by adherence to quantitative physical, chemical, and biological performance standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review panels, not for standard physical/chemical testing of a device like a glove.
- 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 not an AI system nor does it involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is adherence to the specified performance criteria defined by the listed consensus standards (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). These standards define acceptable quantitative limits or qualitative responses (e.g., "not an irritant").
- The sample size for the training set: Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This device does not involve a "training set."
Conclusion:
The FDA document K250313 confirms the clearance of sterile surgeon's gloves based on their adherence to established non-clinical performance and safety standards, including physical properties, sterility, and resistance to chemotherapy drugs and gastric acid. The document explicitly states that "[a] clinical study was not conducted in support of this submission." The questions related to AI/ML, clinical study designs, expert ground truth, and training data are not relevant to this specific device submission.
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