(63 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner,
Latex Patient Examination glove Powderfree
This document describes the acceptance criteria and performance of a latex patient examination glove (powder-free) manufactured by Sempermed Corporation, Ltd.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Description | ASTM Standard / Test Method | Acceptance Criteria | Reported Device Performance (as per table) |
|---|---|---|---|
| Dimension | S-2 AQL 1.0 (for width) | Overall length: 240 +/- 10 mm | |
| Overall length | 230 mm min. | 240 +/- 10 mm | |
| Width (double wall) | S 80 +/- 10 mm, M 95 +/- 10 mm, L 111 +/- 10 mm | SS ≤80 mm, S 83 +/- 5 mm, M 94 +/- 5 mm, L 105 +/- 4 mm | |
| Thickness (finger) | 0.08 mm min. | 0.08 mm min. | |
| Thickness (palm) | 0.08 mm min. | 0.08 mm min. | |
| Physical Properties | S-Z AQL 4.0 | S-2 AQL 4.0 | Met (implies satisfactory, as per conclusion) |
| Tensile strength (before aging) | ASTM D3578-95 | 14 Mpa min. | 14 Mpa min. |
| Elongation at break (before aging) | ASTM D3578-95 | 700% min. | 700% min. |
| Tensile strength (after aging) | 14 Mpa min. | 14 Mpa min. | |
| Elongation at break (after aging) | 500% min. | 500% min. | |
| Water Extractable Protein | N/A | S-2 AQL 4.0, 50 ug/g max. | 50 ug/g max. (implied to be met, see general description for "50 micrograms or less...") |
| Powder Level | N/A | 2 mg max. | 2 mg max. (implied to be met) |
| Freedom From Hole | S-4 AQL 4.0 | II AQL 1.5 | II AQL 1.5 (implied to be met, see conclusion) |
| Human Repeat Insult Patch Test | Extremely low irritation and sensitization potential | "complete lack of reactions," "extremely low" irritation and sensitization potential |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of device performance evaluation. The Acceptance Quality Limit (AQL) values (e.g., S-2 AQL 1.0, S-2 AQL 4.0, S-4 AQL 4.0, II AQL 1.5) indicate the sampling plan for quality control during manufacturing, but not a specific study sample size.
Data Provenance: The device is manufactured by SIAM SEMPERMED CORPORATION Ltd in Thailand. The testing appears to be conducted by or for the manufacturer. The Human Repeat Insult Patch Test was conducted by Concordia Research Laboratories, Inc. (location not specified in snippet, but a US-based company is likely). The document is a 510(k) summary for submission to the FDA, suggesting the data is intended for regulatory review in the US. The timeframe is 1997, making it retrospective data from the perspective of current evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the Human Repeat Insult Patch Test, the document mentions an "investigator and dermatologist" providing an opinion. This suggests at least two experts. Their specific qualifications (e.g., years of experience) are not detailed beyond "dermatologist" and "investigator."
For the other physical and chemical properties, the "ground truth" is established by adherence to ASTM standards and internal specifications, not by expert consensus in the same way. These are objective measurements rather than interpretations.
4. Adjudication Method for the Test Set
For the Human Repeat Insult Patch Test, the "investigator and dermatologist" provided a singular opinion based on the results, implying a consensus or agreement, but no specific adjudication method (like 2+1 or 3+1) is described.
For the physical and chemical properties, adjudication methods are not applicable as the measurements against specified standards are objective.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted for this device. This document describes the performance of a medical device (examination glove) against predefined physical, chemical, and biocompatibility standards, not an AI or diagnostic tool where MRMC studies are typically performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
- ASTM Standards: For most physical properties (dimensions, tensile strength, elongation), the ground truth is defined by adherence to published ASTM (American Society for Testing and Materials) standards, specifically ASTM D3578-95 for latex examination gloves, and internal specifications that meet or exceed these standards.
- Chemical Analysis: For water extractable protein and powder level, the ground truth is established by quantitative chemical analysis compared against defined maximum limits.
- Biocompatibility/Clinical Observation: For the Human Repeat Insult Patch Test, the ground truth is the observed skin reactions (or lack thereof) in human subjects, interpreted by a dermatologist and investigator.
8. The Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning or AI. The product is a manufactured good. Quality control and performance evaluation are based on batch testing and adherence to specifications, not training a model.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" and associated ground truth establishment is not applicable to a physical medical device like an examination glove.
§ 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.