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510(k) Data Aggregation
(88 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. COMFIT MICROPTIC brown surgical gloves are 0.15 mm (minimum) thick single wall to increase finger sensitivity during micro-surgery.
This document describes the acceptance criteria and performance data for "COMFIT MICROPTIC, BROWN BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)".
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D 3577-91) | Reported Device Performance (Children's Surgeon's Gloves - Powdered Type) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on AQL of 1.0 |
| 2. Length (mm) | ||
| Size 5.5 | min 245 | 260 |
| 6.0 | min 265 | 265 |
| 6.5 | min 265 | 265 |
| 7.0 | min 265 | 270 |
| 7.5 | min 265 | 298 |
| 8.0 | min 265 | 298 |
| 8.5 | min 265 | 298 |
| 9.0 | min 265 | 298 |
| 3. Palm width (mm) | ||
| Size 5.5 | $70 \pm 6$ | 72 |
| 6.0 | $76 \pm 6$ | 77 |
| 6.5 | $83 \pm 6$ | 83 |
| 7.0 | $89 \pm 6$ | 89 |
| 7.5 | $95 \pm 6$ | 95 |
| 8.0 | $102 \pm 6$ | 102 |
| 8.5 | $108 \pm 6$ | 108 |
| 9.0 | $114 \pm 6$ | 114 |
| 4. Thickness (mm) | ||
| Finger | min 0.10 | 0.20 |
| Palm | min 0.10 | 0.17 |
| 5. Physical Properties | ||
| Before Ageing: | ||
| Tensile Strength (MPa) | min 24 | 24.97 |
| Ultimate Elongation (%) | min 750 | 862 |
| After Ageing: | ||
| Tensile Strength (MPa) | min 18 | 19.66 |
| Ultimate Elongation (%) | min 560 | 863 |
| Hypoallergenic Claim | No potential for dermal irritation or sensitization | Demonstrated no potential for eliciting either dermal irritation or sensitization in 200 human subjects. |
2. Sample size used for the test set and the data provenance
- Physical and Watertight Tests: The sample size for the physical and watertight tests is not explicitly stated, but the results are reported against the ASTM D 3577-91 standard and FDA 1000 ml watertight test. The AQL (Acceptable Quality Level) of 1.0 for the watertight test suggests a sampling plan was followed. The data provenance is not specified (e.g., country of origin), but it is likely from internal testing by the manufacturer. The data is prospective as it describes the properties of the manufactured gloves.
- Hypoallergenic Test: The test set for the hypoallergenic claim involved 200 Human Subjects. The data provenance is not specified, but it would be prospective for evaluating the product's safety on human skin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes performance tests for physical properties of surgical gloves and a clinical test for hypoallergenic claims. It does not involve expert interpretation or ground truth establishment in the typical sense of medical imaging or diagnostic devices. The "ground truth" for the physical tests is the objective measurement against the ASTM D 3577-91 standard. For the hypoallergenic claim, the "ground truth" is the observed reaction (or lack thereof) in human subjects to the Modified Draize test. No external "experts" are explicitly mentioned for establishing ground truth on these types of tests, other than presumably qualified laboratory personnel and medical professionals overseeing the Modified Draize test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The tests described are objective measurements (e.g., length, thickness, tensile strength) or a clinical observation (Modified Draize test) that do not require an adjudication method among multiple interpreters.
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 is a document for a medical device (surgical gloves) and does not involve AI or human "readers" interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a document for a medical device (surgical gloves) and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Physical Properties: The ground truth for physical properties (e.g., length, width, thickness, tensile strength, elongation) is based on objective measurements compared to an established industry standard (ASTM D 3577-91).
- Watertight Test: The ground truth for the watertight test is also an objective measurement against an established standard (FDA 1000 ml test) and an AQL criterion.
- Hypoallergenic Claim: The ground truth for the hypoallergenic claim is based on clinical observation/outcomes data from a Modified Draize test on human subjects, specifically the absence of dermal irritation or sensitization.
8. The sample size for the training set
Not applicable. This document describes the performance of a physical medical device (surgical gloves) and does not involve machine learning algorithms or a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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