(218 days)
This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.
Latex patient surgeons 'gloves powderfree
Here's a breakdown of the acceptance criteria and study information for the Sempermed Latex Surgeons' Gloves, Powder-Free device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to meeting ASTM Standard D 3577-91 and EN 455/1-3 as the primary acceptance criteria. Specific performance items are listed under "Quality characteristics acc. ASTM D3577-91".
| Description acc. ASTM items | Acceptance Criteria (Spec) | Reported Device Performance |
|---|---|---|
| Sterility Test | Periodical Validation of the process | Validated by Bioservice scientific Laboratories - Germany |
| Freedom from holes | AQL 1.0 (Sampling acc. ISO 2859) | Meets and exceeds FDA pinhole requirements (AQL 1.0) |
| Physical Dimension Test | ||
| 2. Length | 270 - 280 mm related to glove size | (Implied to meet, no specific deviation reported) |
| 3. Width | See table below for glove sizes | (Implied to meet, no specific deviation reported) |
| Glove Size 6 | 79 ±2 mm | (Implied to meet) |
| Glove Size 6.5 | 84 ±3 mm | (Implied to meet) |
| Glove Size 7 | 89 ±3 mm | (Implied to meet) |
| Glove Size 7.5 | 97 ±3 mm | (Implied to meet) |
| Glove Size 8 | 104 ±3 mm | (Implied to meet) |
| Glove Size 8.5 | 110 ±3 mm | (Implied to meet) |
| Glove Size 9 | 114 ±3 mm | (Implied to meet) |
| 4. Thickness | 0.17 - 0.26 mm | (Implied to meet, no specific deviation reported) |
| Physical Requirement Test (Before Aging) | ||
| Tensile Strength MPa, min | 24 MPa | (Implied to meet) |
| Ultimate Elongation % | 750 % | (Implied to meet) |
| Physical Requirement Test (After Aging) | ||
| Stress at 500 % Elongation | 5.5 | (Implied to meet) |
| Tensile Strength MPa | 18 MPa | (Implied to meet) |
| Ultimate Elongation % | 560 % | (Implied to meet) |
| Immunological RAST-inhibition test | (Implied to meet standard, see attached test results) | (See attached test results) |
| Skin irritation test on rabbits | (Implied to meet standard, see attached test results) | (See attached test results) |
| Maximization test/Sensibilisation of skin on genuine-pig | (Implied to meet standard, see attached test results) | (See attached test results) |
Notes on "Reported Device Performance": The document states "Sempermed powderfree surgeons gloves Supreme meets ASTM D 3577-91 and EN 455 standard but exceed FDA pinhole requirements (AQL 1,0)." This implies all listed criteria were met or exceeded, even if specific numerical results are not provided in this summary. The mention of attached test results further supports this.
Regarding Specific Study Details (as requested):
This document describes a 510(k) submission for a medical glove, which is a Class I device. The nature of testing for such devices, especially prior to 1998, focuses on compliance with established standards (like ASTM and EN) rather than complex clinical studies or AI-driven performance evaluations. Therefore, many of the requested details about advanced studies (like MRMC, standalone AI performance, large ground truth expert panels, and specific sample sizes for training/test sets common in AI submissions) are not applicable to this type of device and submission.
Here's an attempt to address the requested points based on the available information:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of AI evaluation. For "Freedom from holes," it mentions "Sampling acc. ISO 2859 (att. 9 - 14/13)". ISO 2859 refers to acceptance sampling procedures, which involve statistical sampling plans to assess quality characteristics. The number of gloves sampled would depend on the lot size and the specific sampling plan used under ISO 2859.
- Data Provenance: The document refers to "Bioservice scientific Laboratories - Germany" for sterility testing. It's likely that other physical and chemical tests were performed internally by Semperit or by other specialized laboratories. The general provenance is Austria (Semperit's location) and Germany (for sterility).
- Retrospective or Prospective: This distinction is not relevant for the type of device testing described. These are laboratory-based, prospective tests on manufactured products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for the performance of these gloves is defined by the technical specifications of ASTM D 3577-91 and EN 455/1-3. Compliance is determined by objective physical, chemical, and sterility tests, not by human expert consensus or clinical judgment on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods are used when there's subjective interpretation involved, typically in imaging or diagnostic AI. The tests for these gloves are objective measurements.
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 studies are for evaluating the impact of AI on human diagnostic performance. This device is a physical product (surgical glove), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is established by objective measurement against predefined physical, chemical, and sterility standards (ASTM D 3577-91 and EN 455/1-3). For example, "Freedom from holes" has a numerical definition (AQL 1.0) and "Tensile Strength" has a minimum MPa value.
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI device for this submission. The manufacturing process of gloves is controlled to meet these standards.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set for an AI model, this question is not relevant. The standards themselves were established by expert committees (e.g., ASTM, CEN) through scientific and technical consensus over time.
§ 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).