(80 days)
The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs.
Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).
This document describes the acceptance criteria and performance of "Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein)".
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Device Performance |
|---|---|---|
| Physical Properties | ||
| Dimension | ASTM Standard D3578-05 | Meets |
| Physical Properties | ASTM Standard D3578-05 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06 | Meets |
| Powder Residual | ASTM Standard D6124-06 (Maximum of 2mg/glove) | Meets (results generated values below 2 mg of residual powder) |
| Protein Level | ASTM Standard D5712-10 (Maximum of 50 mcg/dm² of water soluble protein) | Meets (results generated values below 50 mcg/mg of protein) |
| Biocompatibility | ||
| Biocompatibility | Biological Evaluation of Medical Devices part 1: Evaluation and Testing (ISO 10993-1:2009) | Meets |
| Primary Skin Irritation | Primary Skin Irritation in rabbits (ISO 10993-10:2010) | Gloves are non-irritating |
| Dermal Sensitization | Dermal Sensitization in the guinea pig (ISO 10993-10:2010) | Gloves do not display any potential for sensitization |
| Chemotherapy Permeation | ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs (Minimum Breakthrough Detection Time) | |
| Carmustine (BCNU) (3.3 mg/mL) | Minimum breakthrough detection time is specified by the standard for each drug. The device must meet or exceed this time. For specific claims, the measured time becomes the claim. | Average Breakthrough Detection Time: 15.4 minutes (Note: "extremely low permeation time of less than 30 minutes" is stated, indicating that 15.4 mins is the reported time which must be acceptable based on the standard and drug's known permeability) |
| Cisplatin (1.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Cyclophosphamide (Cytoxan) (20.0 g/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Dacarbazine (DTIC) (10.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Doxorubicin Hydrochloride (2.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Etoposide (20.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Fluorouracil (Adrucil) (50.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Methotrexate (25.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Mitomycin C (0.5mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Paclitaxel (Taxol) (6.0mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Thiotepa (10.0 mg/mL) | Average Breakthrough Detection Time: 1.6 minutes (Note: "extremely low permeation time of less than 30 minutes" is stated, indicating that 1.6 mins is the reported time which must be acceptable based on the standard and drug's known permeability) | |
| Vincristine Sulfate (1.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, physical properties, or chemotherapy permeation). However, it implicitly suggests that testing was conducted in accordance with the cited ASTM and ISO standards, which would define appropriate sample sizes for each evaluation.
The data provenance is not specified in terms of country of origin. The studies appear to be prospective laboratory tests conducted according to established international and US standards (ASTM, ISO, 21 CFR).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the type of device and tests conducted (physical, chemical, and biocompatibility), the "ground truth" is established by adherence to specified, objective, and standardized testing methodologies. This typically involves trained laboratory technicians and/or engineers performing the tests, rather than a panel of "experts" as seen in clinical diagnostic studies. The qualifications would be expertise in conducting the specific ASTM and ISO standard tests. The document does not specify the number or specific qualifications of these individuals.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For objective laboratory tests like those performed on gloves, the results are quantitative and directly compared against the pass/fail criteria of the standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with and without AI assistance, to assess the impact of AI on diagnostic performance. This device is a medical glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not human interpretation of medical cases.
6. If a Standalone Study Was Done
Yes, the studies described are standalone (algorithm/device only) in the sense that the performance of the glove itself was evaluated directly against the specified standards, without involving human users "in the loop" for the primary performance evaluations described. The performance metrics are objective measurements (e.g., tensile strength, pinhole count, breakthrough time, protein levels).
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Established Standards and Regulatory Requirements: The performance is measured against the criteria defined by ASTM standards (D3578-05, D5151-06, D6124-06, D5712-10, D6978-05), ISO standards (10993-1:2009, 10993-10:2010), and U.S. FDA regulations (21 CFR 800.20).
- Objective Laboratory Measurements: Data is generated through physical, chemical, and biological testing protocols designed to yield quantitative and qualitative results that are then compared to the acceptance criteria specified in the standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (medical glove), not an AI algorithm requiring a training set. The performance is assessed through direct testing of the manufactured product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.