(69 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.
Powder free blue nitrile patient exam glove, meets all the requirements of ASTM standard D6319, except for sterility requirements. Non-sterile, powder free, examination gloves made of nitrile and colored blue. The textured gloves are provided in sizes extra small, small, medium, large and extra large. Non-sterile gloves are provided in dispenser boxes.
The provided text describes a 510(k) summary for the "ETS Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. The summary focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D6319 & ASTM D5151 | Meets |
| Powder Residual | ASTM D6124 | Meets (Results generated values below 2mg of residual powder) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10) | Gloves are non-irritating |
| Biocompatibility | Dermal Sensitization in the guinea pig (ISO 10993-10) | Gloves do not display any potential for sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specific tests (e.g., number of gloves tested for dimensions, pinholes, etc.). It only indicates that the device "Meets" the specified ASTM and ISO standards, which inherently include sampling plans within those standards.
- Sample Size: Not explicitly stated for each test. The standards referenced (ASTM D6319, D5151, D6124, ISO 10993-10) would define the required sample sizes for demonstrating compliance.
- Data Provenance: Not explicitly stated. This information is typically generated by the manufacturer or a contracted testing lab during product development and quality assurance. It's retrospective testing of the manufactured product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device. The "ground truth" for patient examination gloves is established by objective, verifiable physical and chemical properties measured against recognized industry standards (ASTM, ISO). There are no human "experts" establishing a subjective ground truth for these performance criteria in the way there would be for, for example, image interpretation in a diagnostic AI study.
4. Adjudication Method for the Test Set
This information is not applicable. As mentioned above, the "ground truth" is determined by objective physical and chemical testing against standards, not by expert consensus or adjudication of subjective interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a Class I medical device (patient examination glove). MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of complex data (like medical images), where the AI might assist a human reader. This device does not involve that type of interaction or assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical product (glove), not an algorithm or software device. Standalone performance refers to the accuracy of an AI algorithm on its own.
7. The Type of Ground Truth Used
The ground truth used is based on objective measurements against established national and international standards. Specifically:
- Physical properties (dimensions, tensile strength, ultimate elongation) are measured against ASTM D6319-10.
- Freedom from pinholes is measured against ASTM D5151-06 and D6319-10.
- Residual powder is measured against ASTM D6124-06.
- Biocompatibility (skin irritation and sensitization) is assessed against ISO 10993-10.
8. The Sample Size for the Training Set
Not applicable. This product is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this device. The manufacturing process is validated (which might involve statistical process control and testing of batches), but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
In summary: The provided 510(k) summary for the ETS Blue Powder Free Nitrile Patient Exam Glove demonstrates its safety and effectiveness by showing that it meets recognized consensus standards (ASTM and ISO) for physical characteristics and biocompatibility, thereby establishing substantial equivalence to a legally marketed predicate device. The nature of this device means that many of the AI/algorithm-specific questions are not relevant.
§ 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.