(158 days)
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. (21CFR 880.6250)
Latex Patient Examination glove , Powder free coated , Non chlorinated , non sterile (White) 50 micrograms or less of total water extractable protein per gram
The provided text describes a 510(k) summary for a "Latex Patient Examination glove, Powder free coated, Non chlorinated, non sterile (White)" manufactured by Siam Sempermed Corp., Ltd. This document is a premarket notification for a medical device and does not contain detailed information about a study with acceptance criteria and device performance in the way a clinical trial report would.
However, it does outline acceptance criteria based on ASTM standards and reported device performance in relation to those standards, as well as protein content and specific biological tests.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|
| Dimensions (ASTM D 3578-00) | Meets ASTM D 3578-00 |
| Physical Properties (ASTM D 3578-00) | Meets ASTM D 3578-00 |
| Protein content | 50 µg/g or less |
| Residue Powder (ASTM D 3578-00) | Meets ASTM D 3578-00 |
| Freedom from pinholes (ASTM D 3578-00) | Meets ASTM D 3578-00 |
| Freedom from pinholes (ASTM D 5151) | Meets ASTM D 5151 |
| Primary Dermal Irritation in Rabbits | Not a primary dermal irritant |
| Guinea Pig Sensitization (Buehler) | Not a sensitizer |
2. Sample size used for the test set and the data provenance
- The document does not specify the sample size used for testing against the ASTM standards (D 3578-00 and D 5151) or for the protein content.
- For the biological tests:
- Primary Dermal Irritation in Rabbits: The experiment reference number is T00-0175. The specific number of rabbits used is not stated in this summary, but generally, such tests involve a small, standardized number of animals.
- Guinea Pig Sensitization (Buehler): The experiment reference number is T01-0112. The specific number of guinea pigs used is not stated, but also involves a standardized number of animals.
- Data Provenance: The tests for biological evaluations (Primary Dermal Irritation and Guinea Pig Sensitization) were conducted by Consumer Product Testing Co. The location or country of origin for the other tests is not explicitly stated beyond the manufacturing location of Siam Sempermed Corp., Ltd. in Thailand. The data appears to be prospective as it was generated to demonstrate compliance for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This document is for a latex examination glove and the "acceptance criteria" are based on established ASTM international standards and specific chemical/biological limits. The "ground truth" is therefore these agreed-upon standards, not expert consensus on interpretations of complex data like medical images.
- The document does not mention the use of experts to establish a "ground truth" for the performance tests in the way clinical studies for AI/diagnostic devices typically do. The tests adhere to objective, measurable standards. The conclusion report is signed by Dr. POONSUK CHERDKIATGUMCHAI, Chief Quality Officer, indicating an internal quality assurance role.
4. Adjudication method for the test set
- Not applicable as the "ground truth" is based on objective, standardized measurements against ASTM specifications and laboratory test results, rather than expert interpretation requiring adjudication.
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 medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical glove and does not involve any algorithm or AI component.
7. The type of ground truth used
- The "ground truth" for the device's performance is based on established manufacturing and material standards (ASTM D 3578-00 and ASTM D 5151), chemical specifications (protein content), and biological safety tests (primary dermal irritation and sensitization). This is a form of objective measurement-based ground truth.
8. The sample size for the training set
- Not applicable. This device is a physical medical glove and does not involve machine learning or a 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.