(67 days)
A powder free latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Natural Rubber Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standards / Acceptance Criteria | Device Performance |
|---|---|---|
| Dimensions | ASTM D3578 - 05 | Meets |
| Physical Properties | ASTM D 412 - 06ae1 | Meets |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Soluble Protein Level | ASTM D 5712 - 05 (also protein labeling claim of 50 micrograms per dm² of glove or less) | Meets (with protein labeling claim of 50 micrograms per dm² of glove or less) |
| Biocompatibility: | ||
| - Dermal Sensitization | Dermal Sensitization (as per ASTM F720-81) | Not a contact skin sensitizer |
| - Skin Irritation | Primary Skin Irritation Test (as per 16CFR Part1500) | Not a primary skin irritant |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each of the tests (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Soluble Protein Level, Biocompatibility).
The data provenance is not specified beyond indicating these are "performance test data." It is highly likely these were conducted as prospective tests by the manufacturer, specifically for this submission. The country of origin of the data would be Malaysia, where WEAR SAFE (MALAYSIA) SDN. BHD. is located and conducted the testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are objective, laboratory-based physical and chemical assays, and biocompatibility tests. They rely on standardized methods rather than expert interpretation of data like in an imaging study. Therefore, the concept of "experts establishing ground truth" in the way it might apply to medical imaging or diagnostics is not directly relevant here. The ground truth for these tests is defined by the objective measurement criteria of the specified ASTM and CFR standards.
4. Adjudication method for the test set:
Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers might disagree on findings (e.g., radiologists interpreting images). Since these are objective physical, chemical, and biocompatibility tests, no adjudication method in this sense would have been used. The results are based on direct measurements and observations according to the test protocols.
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:
No MRMC comparative effectiveness study was done. This device is a patient examination glove, a physical product, not an AI-powered diagnostic or assistive technology. The concept of "human readers improving with AI assistance" is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was done. This is a physical non-AI device.
7. The type of ground truth used:
The ground truth for these tests is based on objective measurement criteria and thresholds defined by established international standards:
- ASTM D3578-05 for Dimensions
- ASTM D 412-06ae1 for Physical Properties
- ASTM D 5151-06 for Freedom from pin-holes
- ASTM D 6124-06 for Powder Free Residue
- ASTM D 5712-05 for Soluble Protein Level
- ASTM F720-81 for Dermal Sensitization
- 16CFR Part 1500 for Primary Skin Irritation Test
These standards specify the methodology and acceptable limits for each characteristic.
8. The sample size for the training set:
Not applicable. This device is a physical product, 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 there is no training set for this type of 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.