(87 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.
The product is a powder-free, sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and 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.
Here's an analysis of the acceptance criteria and study information for the Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM/ISO Standards) | Reported Device Performance |
|---|---|
| ASTM D 3578-01a Requirements: | |
| - Freedom from holes | Meets all ASTM D 3578-01a requirements |
| - Physical properties (except ultimate elongation before aging) | Meets all ASTM D 3578-01a requirements for physical properties, except ultimate elongation before aging. However, it meets the same requirements as the gloves cleared under K011198 (the predicate device). This implies that the predicate device also had this exception, and it was deemed acceptable. |
| - Physical dimensions | Meets all ASTM D 3578-01a requirements |
| ISO 10993-Part 10 (Biological Evaluation - Irritation & Sensitization): | |
| - Non-irritating | The gloves have been tested and shown to be non-irritating. |
| - Non-sensitizing | The gloves have been tested and shown to be non-sensitizing. |
| ASTM-6124-01 Requirements: | |
| - Labeling as powder-free | Meets requirements of ASTM-6124-01 for labeling as powder free. No powders are utilized in the manufacturer of this glove. |
| Material Equivalence: | |
| - Same polymer materials as K011198 predicate device | The glove is manufactured using the same polymer materials as described in K011198. |
| General Safety and Efficacy (relative to predicate): | |
| - No adverse changes to safety and efficacy | There are no adverse changes to the safety and efficacy of the glove products in this submission. The only difference is the sterilization process and packaging change. All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices. The product will be manufactured to the specifications and per documented label claims in K011198. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., freedom from holes, physical properties, irritation, sensitization). It only indicates that the gloves meet the requirements of the standards or have been tested.
The provenance of the data is not specified (e.g., country of origin). Since it's a 510(k) submission to the FDA, it's generally expected that the testing would be conducted in a manner compliant with US regulatory guidelines or internationally recognized standards. The document does not specify if the testing was retrospective or prospective, but given it's for a new clearance, it would typically involve prospective testing of the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For manufacturing and material strength tests like ASTM D 3578-01a or ASTM-6124-01, "experts" in the sense of human interpretation of complex medical images or conditions are typically not involved. These are objective, quantitative tests performed by trained laboratory technicians following standardized protocols. For ISO 10993-Part 10 (biocompatibility), the "ground truth" (i.e., non-irritating/non-sensitizing) is established through standardized animal or in vitro tests, not expert consensus on human data.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective, standardized laboratory tests. There is no indication of subjective assessment or an adjudication process involved in these performance evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
Not applicable. This is a submission for a sterile medical examination glove, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a medical device (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for the performance claims relies on:
- Standardized Test Results: Compliance with established industry standards like ASTM D 3578-01a, ISO 10993-Part 10, and ASTM-6124-01. These standards define the methods and criteria for evaluating factors like freedom from holes, physical properties, biocompatibility (irritation/sensitization), and powder content.
- Predicate Device Equivalence: The claim of substantial equivalence to the predicate device (K011198) in terms of materials, physical properties, and safety/efficacy. The predicate device's existing clearance serves as a form of "ground truth" for acceptable performance.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of a physical medical device like a glove. The device's manufacturing processes and material specifications are developed based on engineering principles and existing knowledge, not through machine learning training.
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 "ground truth" for the device's design and manufacturing is established through compliance with recognized standards, validated manufacturing processes, and comparison to existing, cleared predicate devices.
§ 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.