(111 days)
The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91.
Here's the analysis of the acceptance criteria and the supporting study for the Comfit Brown Beaded Surgeon's Gloves, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D 3577-91) | Reported Device Performance (COMFIT Brown Beaded Surgeon's Gloves) |
|---|---|---|
| Watertight | S-4, AQL 1.5 | Pass based on AQL of 1.0 |
| Length (mm) | ||
| Size 5.5 | min 245 | 260 |
| Size 6.0 | min 265 | 265 |
| Size 6.5 | min 265 | 265 |
| Size 7.0 | min 265 | 270 |
| Size 7.5 | min 265 | 302 |
| Size 8.0 | min 265 | 302 |
| Size 8.5 | min 265 | 302 |
| Size 9.0 | min 265 | 302 |
| Palm Width (mm) | ||
| Size 5.5 | 70 ± 6 | 72 |
| Size 6.0 | 76 ± 6 | 77 |
| Size 6.5 | 83 ± 6 | 83 |
| Size 7.0 | 89 ± 6 | 89 |
| Size 7.5 | 95 ± 6 | 96 |
| Size 8.0 | 102 ± 6 | 102 |
| Size 8.5 | 108 ± 6 | 108 |
| Size 9.0 | 114 ± 6 | 114 |
| Thickness (mm) | ||
| Finger | min 0.10 | 0.25 |
| Palm | min 0.10 | 0.21 |
| Physical Properties (Before Ageing) | ||
| Tensile Strength (MPa) | min 24 | 26.0 |
| Ultimate Elongation (%) | min 750 | 855 |
| Physical Properties (After Ageing) | ||
| Tensile Strength (MPa) | min 18 | 23.4 |
| Ultimate Elongation (%) | min 560 | 890 |
2. Sample Size Used for the Test Set and Data Provenance
For the physical and watertight tests (ASTM D 3577-91 and FDA 1000 ml watertight test), the sample size is not explicitly stated in the provided text. However, the Watertight test mentions an "AQL of 1.0" which implies a sampling plan was used according to the ASTM standard.
For the "hypoallergenic" claim:
- Sample size: 200 human subjects.
- Data provenance: Not explicitly stated, but it refers to a "Clinical data of 200 Human Modified Draize test," suggesting a prospective clinical study involving human volunteers. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- For physical and watertight tests: No "experts" in the sense of medical professionals are mentioned for establishing ground truth for these objective performance metrics. The ground truth is established by the specifications defined in ASTM D 3577-91 and the FDA 1000 ml watertight test, which are industry standards. Testing would be performed by lab personnel following these standard procedures.
- For the hypoallergenic claim: The "Modified Draize test" is a recognized method for assessing skin irritation and sensitization. The results would be interpreted by qualified personnel (e.g., dermatologists or toxicologists) according to standard protocols for assessing reactions. However, the specific number and qualifications of experts are not provided in this document.
4. Adjudication Method for the Test Set
- For physical and watertight tests: Adjudication is not applicable in the conventional sense. Performance is measured against fixed, objective criteria defined by the ASTM standard and FDA test. It's a pass/fail determination based on quantitative results.
- For the hypoallergenic claim: The "Modified Draize test" involves observations of skin reactions. While the text doesn't explicitly state an adjudication method (e.g., blinded readings, consensus panels), standard practice for such tests would involve trained observers assessing the dermal responses based on a predefined scoring system.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported. This device is a medical glove, and the performance criteria are physical and biological (hypoallergenic), not related to image interpretation or diagnostic tasks where AI assistance for human readers would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a medical device like a surgeon's glove. The device itself is the "product" being tested, not an algorithm. The performance data presented pertains to the physical and biological properties of the glove itself.
7. The Type of Ground Truth Used
- For physical and watertight tests: The ground truth is established by objective engineering and material science standards (ASTM D 3577-91) and a regulatory agency defined test (FDA 1000 ml watertight test).
- For the hypoallergenic claim: The ground truth for hypoallergenic potential is established through a clinical test on human subjects (Modified Draize test) designed to assess dermal irritation and sensitization.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as the document describes the testing of a physical medical device (a glove), not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable due to the reasons stated above (no algorithm, no training set).
§ 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).