(98 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.
Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile meets all of the requirements of ASTM D 6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or white color.
Here's a breakdown of the acceptance criteria and study information for the device, based on the provided text:
Acceptance Criteria and Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from Pinholes | ASTM D 5151-06, ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6124-06, ASTM D 6319-10 | Meets |
| Biocompatibility: | ||
| - Dermal Sensitization | ISO 10993-10:2010 | Not a contact skin sensitizer |
| - Primary Skin Irritation | 16 CFR Part 1500 (Primary Skin Irritation Test) | Not a primary skin irritant |
Study Information
The provided document describes a 510(k) Premarket Notification for a medical device (Powder Free Nitrile Patient Examination Glove). For this type of submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than conducting extensive clinical studies to prove effectiveness from scratch. Therefore, the "study" mainly refers to the non-clinical performance data demonstrating compliance with established standards.
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., how many gloves were tested for pinholes, dimensions, etc.). It generally states that the device "Meets" the respective ASTM and ISO standards, implying that the number of samples tested was sufficient to establish conformity according to those standards.
- Data Provenance: The testing was performed by the manufacturer, WSM WEAR SAFE (MALAYSIA) SDN BHD, located in Malaysia. The data is retrospective, as it refers to performance tests conducted on the device to demonstrate compliance with standards for the 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to this submission. The "ground truth" for glove performance is established by widely accepted international and national standards (ASTM, ISO, CFR). The experts involved would be the engineers and quality assurance personnel at the manufacturing facility who conducted the tests and verified compliance with these objective standards. Their qualifications are inherent in their ability to perform and interpret these standardized tests.
3. Adjudication method for the test set:
- Not applicable in the context of expert adjudication for clinical outcomes. The "adjudication" here is the comparison of the device's measured performance against the quantitative and qualitative requirements outlined in the specified standards. Compliance is determined by whether the test results fall within the acceptable ranges or pass/fail criteria of those standards.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not done. The device in question is a patient examination glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader improvement with or without AI assistance is irrelevant and not performed.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not done. Again, this is a physical medical device (glove), not a software algorithm. The concept of "standalone" algorithm performance does not apply.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on established industry standards and regulatory requirements. For example:
- Dimensions, Physical Properties, Freedom from Pinholes, Powder Free Residue: The ground truth is defined by the specifications and test methods outlined in ASTM D 6319-10, ASTM D 5151-06, and ASTM D 6124-06.
- Biocompatibility: The ground truth for biocompatibility is defined by the test methods and acceptance criteria specified in ISO 10993-10:2010 (for dermal sensitization) and 16 CFR Part 1500 (for primary skin irritation).
7. The sample size for the training set:
- Not applicable. This device is a physical medical product, not a machine learning model, so there is no "training set." The manufacturing process would have internal quality control and verification procedures, but these are distinct from AI model training.
8. How the ground truth for the training set was established:
- Not applicable. As there is no training set, the question of how its ground truth was established is 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.