(22 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. It is made with a poly (viny) Chloride) polymer and a polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed as medical examination gloves.
The provided text describes the regulatory clearance for Maxxim Medical's Tru-Touch™ PF Vinyl Powder Free Medical Examination Gloves. It focuses on demonstrating substantial equivalence to a previously cleared device (SensiCare™ Powder Free Vinyl Medical Examination gloves, K944182) rather than conducting a new comprehensive study with detailed acceptance criteria and performance data for a novel device.
As such, many of the requested elements for a study proving device meets acceptance criteria are not present in this type of submission. This document is a 510(k) premarket notification for a Class I medical device, which primarily relies on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM/ISO Standards) | Reported Device Performance |
|---|---|
| Freedom from holes, physical properties, and physical dimensions (ASTM D 5250-92 requirements) | "The gloves meet all ASTM D 5250-92 requirements for freedom from holes, physical properties and physical dimensions." (Explicitly stated as met, specific values/metrics for "freedom from holes, physical properties, and physical dimensions" are not detailed in this summary for the Tru-Touch™ PF Vinyl gloves. It's implied they meet the standard's specifications.) |
| Non-irritating and non-sensitizing (ISO10993-Part 10) | "The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO10993-Part 10." (Explicitly stated as met.) |
| Powder-free labeling (ASTM D 6124-97) | "The gloves meet requirements of ASTM D 6124-97 for labeling as powder free. No powders are utilized in the manufacture of this glove." (Explicitly stated as met. This also aligns with the "Powder Free" in the device name.) |
| Does not contain any natural rubber latex | "The glove is manufactured from a polymer and does not contain any natural rubber latex." (Explicitly stated as met. This is a material specification rather than a performance test, but it's a key characteristic.) |
| Physical properties and dimensions for medical examination glove intended use (implied, not a specific standard listed here but generally covered by ASTM D 5250-92) | "All requirements for physical properties and dimensions have been met for this intended use [medical examination gloves]." (General statement of compliance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for testing against ASTM and ISO standards. Standard test methods usually define required sample sizes, but these are not disclosed in this summary.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical product like a glove, it's highly likely the testing was prospective (i.e., new tests were performed on the Tru-Touch™ PF Vinyl gloves).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to the evaluation of medical examination gloves against material and performance standards. Ground truth for these criteria is established by objective, standardized laboratory tests (e.g., tensile strength, elongation, pinhole detection, chemical irritation tests), not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
- Not applicable for the types of tests described. Results for physical and chemical properties are typically quantitative or pass/fail based on established standard thresholds, not subject to human adjudication in the way, for example, image interpretation or clinical outcomes might be.
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 typically used for diagnostic devices (e.g., imaging software) where human readers interpret results, and the AI's impact on their performance is evaluated. This is not relevant for medical examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device. The "performance" being discussed relates to the glove's physical and chemical properties.
7. The Type of Ground Truth Used
- The ground truth for the performance criteria (e.g., freedom from holes, physical properties, non-irritation) is based on objective, standardized test methods and established thresholds defined within the referenced ASTM and ISO standards (e.g., ASTM D 5250-92, ISO 10993-Part 10, ASTM D 6124-97). These are laboratory-based, quantitative assessments.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of physical medical examination gloves. This term typically refers to data used to train machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set 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.