(31 days)
This powder-free vinyl exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
A 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.
The device is powder-free vinyl exam gloves. They are non-sterile, single use, disposable gloves.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GLORMED INTERNATIONAL, INC. VINYL EXAMINATION GLOVE, POWDER-FREE:
It's important to note that this document is a 510(k) Summary for a medical glove, which is a relatively low-risk device. The regulatory requirements and the nature of the "study" for such devices are much simpler than for complex AI-powered diagnostic tools. Therefore, many of the requested categories (like MRMC studies, ground truth establishment for training data, number of experts for ground truth, etc.) are not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Device Performance |
|---|---|
| ASTM D5250 | Met and/or exceeded the requirements. (This standard specifies requirements for medical grade vinyl examination gloves.) |
| Primary Skin Irritation Study | Met and/or exceeded the requirements. (Implies no significant primary skin irritation was observed.) |
| Dermal Sensitization Study | Met and/or exceeded the requirements. (Implies no significant dermal sensitization was observed.) |
| FDA Water Leak, before & after aging | Met and/or exceeded the requirements. (This test assesses the integrity of the glove to prevent leakage, both initially and after simulated aging, which is critical for barrier protection. The specific threshold is not provided.) |
Study Details
Given the nature of the device (a vinyl examination glove), the "study" is a series of laboratory tests to demonstrate compliance with relevant standards and safety requirements.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. For physical property tests like water leak, ASTM standards typically specify a sampling plan (e.g., AQL levels). For biocompatibility tests (skin irritation, sensitization), testing is typically done on a representative biological model or a small group of human volunteers.
- Data Provenance: Not specified, but the tests were performed "in a certified testing laboratory." The country of origin of the data is not mentioned, but it's presumed to be from a laboratory that can provide data acceptable to the FDA for a US market submission. The tests are prospective in the sense that they were conducted specifically for this device submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For physical and chemical tests of a medical glove, "ground truth" is established by the objective physical and chemical properties of the glove itself, as measured by standard laboratory procedures. Biocompatibility studies are typically evaluated by toxicologists or dermatologists, but the number of "experts" for ground truth adjudication in the AI sense is not relevant here.
4. Adjudication method for the test set:
- Not Applicable. As per point 3, adjudication in the context of expert consensus for AI is not relevant for these types of lab tests. The tests have pass/fail criteria based on standards.
5. 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:
- Not Applicable. This device is a physical product (medical glove), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used:
- Objective Test Results against Standards. The "ground truth" for the performance claims of the glove is the objective data obtained from the specified laboratory tests (e.g., water leak test, tensile strength implicit in ASTM D5250, results of irritation and sensitization studies) compared against the acceptance criteria defined by the relevant ASTM standards and FDA requirements.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for a physical device.
§ 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.