(66 days)
A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.
Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
The document describes the acceptance criteria and performance data for Innovative Gloves Company Limited's Nitrile Examination Gloves Powder-Free (Black Color).
This is a premarket notification (510(k)) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive de novo clinical trials with independent ground truth establishment or MRMC studies. The "study" here refers to the testing performed against recognized standards.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Non-Clinical Tests | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Physical Properties | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Freedom from pinholes | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Powder Free | ASTM D 6319-00a | Meets ASTM D 6319-00a requirements | Meets |
| Clinical Tests | Standard | Acceptance Criteria | Reported Device Performance |
| Skin Irritation Study | ISO 10993, Part 10:2002(E) | Meets ISO 10993, Part 10:2002(E) | Meets |
| Skin Sensitization Study | ISO 10993, Part 10:2002(E) | Meets ISO 10993, Part 10:2002(E) | Meets |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, number of participants for skin irritation). It only states that the device "Meets" the specified standards. ASTM and ISO standards for medical gloves typically specify sampling plans and test methods, but the raw data or detailed sample sizes are not provided in this summary.
- Data Provenance: The tests were conducted by Innovative Gloves Company Limited, based in Thailand. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance with the relevant standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable in the context of this device and report. The "ground truth" here is adherence to established international and national standards (ASTM and ISO) for physical properties and biocompatibility. There isn't an "expert consensus" in the way one would establish ground truth for an AI diagnostic algorithm for image interpretation. The standards themselves define the criteria for "ground truth" performance.
4. Adjudication Method for the Test Set
- Not applicable. The tests are laboratory-based and objective measurements against established standard specifications, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-assisted diagnostic tool for which MRMC studies are typically performed.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
- Not applicable. This device is a physical product (a glove), not an algorithm.
7. Type of Ground Truth Used
- The ground truth for this device's performance is established by the specifications and methodologies outlined in the referenced international standards (ASTM D 6319-00a and ISO 10993, Part 10:2002(E)). These standards define acceptable ranges for dimensions, physical properties, pinhole freedom, powder content, and biological reactivity.
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI model that requires a training set. The manufacturing process is controlled, and quality control tests (which are the "performance" data here) are done on samples from production batches.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical medical device like a glove.
§ 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.