(43 days)
A powder-free 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. 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 by Chemotherapy Drugs.
These patient examination gloves are formulated using Nitrile. They are a disposable device that is offered powder-free and nonsterile. Gloves are comflower blue in color. Gloves are not made with natural rubber latex.
This document describes the acceptance criteria and the studies performed for the Cardinal Health Nitrile Powder-Free Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Primary Skin Irritation (non-irritating) | Gloves are non-irritating. |
| Guinea Pig Maximization (no sensitization potential) | Gloves do not display any potential for sensitization. |
| Physical Characteristics: | |
| Dimensions (meets ASTM D6319 requirements) | Gloves meet requirements of ASTM D6319. |
| Physical Characteristics per ASTM D6319 | Gloves meet requirements for Nitrile examination gloves per ASTM D6319. |
| Freedom from Holes (meets 21 CFR 800.20 and ASTM D6319) | Gloves meet requirements of 21 CFR 800.20 and ASTM D6319. |
| Powder Residual (below 2mg/glove per ASTM D6319 & D6124) | Results generated values below 2mg of residual powder per glove, meeting powder level requirements for "Powder-Free" designation. |
| Chemotherapy Permeation (ASTM D6978): | Break-through detection time (minimum 0.01 µg/cm²/minute) |
| Carmustine (BCNU) (3.3 mg/ml) | 7.28 minutes |
| Cisplastin (1.0mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | >240 minutes |
| Doxorubicin HCl (2.0 mg/ml) | >240 minutes |
| Etoposide (Toposar) (20 mg/ml) | >240 minutes |
| 5-Fluorouracil (50 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes |
| Thiotepa (10 mg/ml) | 2.67 minutes |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for physical characteristics, number of samples per drug for chemotherapy permeation).
- However, the tests were conducted in accordance with established ASTM (American Society for Testing and Materials) standards (D6319, D6124, D6978) and 21 CFR 800.20. These standards typically define the appropriate sample sizes for such tests to ensure statistical validity.
- The data provenance is not explicitly stated as "country of origin" but implies the studies were conducted to US regulatory standards (FDA 510(k) submission). The data is retrospective as it was gathered to support a premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable in the context of this device. The "ground truth" for examination gloves is established through objective, standardized physical and chemical laboratory tests, not through expert consensus on interpretations of data or images. For example, chemical permeation is measured directly, not adjudicated by an expert.
4. Adjudication Method for the Test Set:
- Not applicable. The tests involve objective measurements against predefined standards and thresholds, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where human interpretation of images/data is a factor, often with AI assistance. Examination gloves do not involve such a human-in-the-loop diagnostic process.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Not applicable. This device is an examination glove, not an algorithm or AI system. Its performance is entirely "standalone" in the sense that it is a physical product designed to meet certain performance specifications through laboratory testing.
7. The Type of Ground Truth Used:
- The ground truth used for this device is based on objective, standardized laboratory measurements and performance specifications. These include:
- Physical properties: such as dimensions, tensile strength, elongation, and freedom from holes, measured against the requirements of ASTM D6319 and 21 CFR 800.20.
- Biocompatibility properties: such as primary skin irritation and sensitization, assessed through established animal testing protocols.
- Chemical permeation resistance: measured experimentally using ASTM D6978 to determine breakthrough times for chemotherapy drugs.
- Residual powder levels: measured using ASTM D6124.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its effectiveness is proven through direct physical and chemical testing of manufactured gloves.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as no training set was used for this 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.