(142 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder-Free Polymer Coated Latex Examination Gloves with Protein Labeling (50microgram or less of total water extractable proteins per square decimeter of gloves), non-sterile.
The provided text describes the acceptance criteria and performance of Powder-Free Polymer Coated Latex Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Physical Properties | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Freedom From Holes | Meets ASTM D 3578-05, AQL 1.5; Meets ASTM D 5151-06 | Meets ASTM D 3578-05, AQL 1.5; Meets ASTM D 5151-06 |
| Protein Content | Meets ASTM D 5712-99, Less than 50µg/dm² | Less than 50µg/dm² (stated in device name and description) |
| Powder Free Residue | Meets ASTM D 6124-06, Less than 2 mg per glove | Less than 2 mg per glove |
| Biocompatibility | Passes Primary Skin Irritation in Rabbits Test (Consumer Product Safety Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4)) | Passes Primary Skin Irritation in Rabbits Test |
| Biocompatibility | Passes Guinea Pig Sensitization Test (ISO 10993-10: 2002(E), Dermal Sensitizations Assay- Closed Patch Test) | Passes Guinea Pig Sensitization Test |
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 test (e.g., freedom from holes, protein content, biocompatibility). It references ASTM and ISO standards, which would typically specify sampling plans.
The data provenance is not explicitly stated in terms of country of origin but is presented as nonclinical test results performed on the device. Given the applicant is THAI HUA HOLDING CO., LTD. based in Bangkok, Thailand, it is reasonable to infer the tests were conducted in facilities related to their operations or authorized testing laboratories. The data appears to be retrospective as it's presented to demonstrate that the manufactured device meets established standards.
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 "ground truth" for the device's performance is established by its adherence to specified ASTM and ISO standards, which are themselves expert-developed and widely accepted.
4. Adjudication method for the test set:
This information is not provided. The assessment method relies on the device meeting numerical or qualitative criteria defined by the referenced standards, rather than expert adjudication of subjective outcomes.
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, an MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-assisted diagnostic or imaging tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical product (medical glove) and does not involve any algorithms or AI for its function.
7. The type of ground truth used:
The ground truth used is based on established national and international standards for medical gloves. Specifically:
- ASTM D 3578-05 Standard Specification for Rubber Examination Gloves for dimensions, physical properties, and freedom from holes.
- ASTM D 5151-06 for freedom from holes.
- ASTM D 5712-99 for protein content.
- ASTM D 6124-06 for powder-free residue.
- Consumer Product Safety Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4) for primary skin irritation.
- ISO 10993-10: 2002(E) for guinea pig sensitization.
These standards provide objective, measurable criteria which serve as the "ground truth" for the device's acceptable performance.
8. The sample size for the training set:
This concept is not applicable as the device is a physical product and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
This concept is not applicable for the reasons stated in point 8.
§ 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.