(81 days)
A surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hands during surgical operations to prevent contamination between patient surgeon's
Latex Surgeon's Gloves Pre-Powdered Sterile
The provided document is a 510(k) summary for "Latex Surgeon's Gloves Pre-Powdered Sterile" from PT. MAJA AGUNG LATEXINDO. It details the device's characteristics, performance criteria, and a statement that the performance data meets these criteria.
Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Before ageing) | Acceptance Criteria (After ageing at 70°C 168 hrs) | Reported Device Performance (Implied) |
|---|---|---|---|
| Dimensions: | Meets ASTM D 3577 Standard | ||
| Length mm (min.) Sizes | 265 | N/A | Reported as meeting criteria |
| Palm Width mm (for sizes) | $83 \pm 6$ to $108 \pm 6$ | N/A | Reported as meeting criteria |
| Thickness 1. Cuff mm (min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 2. Palm mm(min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 3. Finger Tip mm | 0.10 | N/A | Reported as meeting criteria |
| Physical Properties: | Meets ASTM D 3577 Standard | ||
| Tensile Strength | 24 Mpa (min) | 18 Mpa (min) | Reported as meeting criteria |
| Ultimate Elongation | 750 % (min.) | 560 % (min.) | Reported as meeting criteria |
| Stress at 500 % Elongation | 5.5 (max) | N/A | Reported as meeting criteria |
| Performance Requirements: | |||
| Watertight (Holes) | AQL 1.5 | N/A | Meets FDA pin hole requirement |
| Dimensions | AQL 4.0 | N/A | Reported as meeting criteria |
| Physical Properties | AQL 4.0 | N/A | Reported as meeting criteria |
| Sterility | Not Acceptable for Fails Sterility | N/A | Meets the sterility assurance level |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It refers to "Inspection Level S-4" and "S-2" and "AQL" values for performance characteristics, which imply sampling plans were used according to standards like ASTM or ISO, but the exact number of units tested is not provided.
- Data Provenance: The data appears to be from the manufacturer, PT. MAJA AGUNG LATEXINDO, based in Indonesia. The nature of the data (retrospective or prospective) is not specified, but it represents testing conducted to demonstrate compliance with 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 established ground truth for performance characteristics is based on objective measurements and adherence to ASTM D 3577 and FDA requirements, rather than expert consensus on subjective findings.
4. Adjudication method for the test set
This information is not provided in the document. Given the objective nature of the tests (dimensions, tensile strength, elongation, watertightness, sterility), an adjudication method in the context of expert review would likely not be applicable. The results would be a direct measurement against the specified criteria.
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 study was done. This device is a physical product (latex surgeon's gloves), not an AI-assisted diagnostic or therapeutic tool. Therefore, a study comparing human reader performance with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As the device is a physical product, there is no algorithm or AI component to perform in a standalone manner.
7. The type of ground truth used
The ground truth used for this device is based on objective measurement against established industry standards and regulatory requirements.
- ASTM D 3577 Standard: For dimensions and physical properties.
- FDA pin hole requirement: For watertightness.
- Sterility Assurance Level: For sterility.
These are well-defined, quantitative standards.
8. The sample size for the training set
- Not applicable. This device is a physical product; there is no machine learning model or algorithm that requires a "training set" in the conventional sense. The product design and manufacturing processes are likely informed by industry experience and engineering principles rather than a data-driven training set.
9. How the ground truth for the training set was established
- Not applicable. As explained above, there is no training set for this type of device. The "ground truth" for ensuring the quality of the manufacturing process would be established through quality control procedures, adherence to Good Manufacturing Practices (GMP), and material specifications, all designed to meet the performance standards.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).