(81 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, polyurethane examination glove that is available in various sizes. It is made with a polyurethane 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 both as medical examination gloves and dental examination gloves.
Acceptance Criteria and Device Performance for Maxxim Medical Polyurethane Powder Free Medical/Dental Examination Gloves
This document summarizes the acceptance criteria and the study results demonstrating that the Maxxim Medical Polyurethane Powder Free Medical/Dental Examination Gloves meet these criteria, as presented in the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ASTM D 3578-95 Requirements | |
| - Freedom from holes | Met |
| - Physical properties (except ultimate elongation before aging) | Met (explicitly states "except ultimate elongation before aging" for the D 3578-95 requirements, implying other physical properties were met) |
| - Physical dimensions | Met |
| ISO 10993-Part 10 Requirements | |
| - Non-irritating and non-sensitizing | Met (tested in accordance with ISO10993-Part 10 and shown to be non-irritating and non-sensitizing) |
| ASTM D 6124-97 Requirements | |
| - Labeling as powder free | Met (device meets requirements for labeling as powder free; "No powders are utilized in the manufacture of this glove.") |
| Does not contain natural rubber latex | Met (the glove is manufactured from a polymer and does not contain any natural rubber latex) |
| Physical properties and dimensions for medical/dental examination uses (compared to predicate devices) | Met (All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices: Nitra-Touch™ Nitrile Powder Free Medical Examination gloves (K965095) and SensiCare™ Powder Free Vinyl Medical Examination gloves (K944182). Specific data not provided in summary.) |
| Polyurethane coating provides good donning and doffing without donning powder, release powder, or chemicals | Implied Met (the polyurethane coating on the user side provides good donning and doffing without the use of donning powder; "No release powder or chemical release agents are used.") |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes used for the testing. It generally states that "The results of the safety, efficacy and performance testing of the Polyurethane Powder Free Examination Gloves are submitted in this 510(k) submission." The tests appear to be primarily retrospective, as they involve testing manufactured gloves against established standards. The data provenance is implied to be from testing conducted by or for Maxxim Medical, Inc. in the United States (given the submission to the FDA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Based on the information provided, no "experts" in the sense of clinical specialists or radiologists were used to establish ground truth. The "ground truth" for the performance criteria is defined by industry standards (ASTM, ISO). Compliance with these standards is typically assessed through laboratory testing and measurement by trained technicians and engineers, rather than expert interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The assessment of compliance with standard specifications (e.g., freedom from holes, physical properties) is typically objective and based on direct measurement or established test protocols with defined acceptable limits, not on subjective expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. This is not applicable to a device like examination gloves, which are assessed based on physical and material properties, not diagnostic interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The device (the glove itself, an "algorithm" is not applicable here) was tested to directly assess its compliance with various standards (ASTM D 3578-95, ISO 10993-Part 10, ASTM D 6124-97) and its physical properties. This testing was performed independent of human-in-the-loop interaction for the specific performance parameters mentioned.
7. Type of Ground Truth Used
The ground truth used is primarily objective industry standards and test specifications (ASTM D 3578-95, ISO 10993-Part 10, ASTM D 6124-97). Additionally, a form of ground truth is established by comparison to predicate devices (K965095 and K944182) for overall physical properties and dimensions.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (medical glove), not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The manufacturing process and formulation could be considered the "training" in a very loose sense, but that's not what is typically meant by a training set in medical device submissions related to AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are likely informed by years of experience in glove production, material science, and feedback from existing products, which could be seen as an iterative development process but not a formal "training set" with established ground truth labels for an algorithm.
§ 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.