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510(k) Data Aggregation
(186 days)
A glove is wom on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment
Latex Patient Examination glove ( color)
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
The provided document describes a Class I Latex Patient Examination Glove. The "study" referenced in this context is the testing and adherence to established ASTM (American Society for Testing and Materials) standards for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (ASTM Standard & Specification) | Reported Device Performance |
|---|---|---|
| DIMENSION | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Overall length | 230 mm min. | 240⁺⁄⁋10 mm |
| Width (double wall) | S 80 ⁺⁄⁋ 10 mm | SS 77 ⁺⁄⁋ 5 mm |
| M 95 ⁺⁄⁋ 10 mm | S 83 ⁺⁄⁋ 5 mm | |
| L 111 ⁺⁄⁋ 10 mm | M 94 ⁺⁄⁋ 5 mm | |
| L 105 ⁺⁄⁋ 4 mm | ||
| Thickness, mm Finger | 0.08 mm MIN. | 0.08 mm MIN. |
| Thickness, mm Palm | 0.08 mm MIN. | 0.08 mm MIN. |
| PHYSICAL PROPERTIES | S -2 AQL 4.0 | S-2 AQL 4.0 |
| Before Aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN |
| Elongation at break | 700 % MIN. | 700% MIN. |
| After Aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN. |
| Elongation at break | 500% MIN. | 500% MIN. |
| POWDER LEVEL | N/A (ASTM standard not specified) | |
| Inside | S-2 AQL 4.0 | 2.5⁺⁄⁋1.0% |
| Outside | 1.0% MAX. | |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
The document states that the Latex patient examination glove (color) - 80LYY meets all of the requirements of ASTM standard D3578-95, and the table above reinforces this by showing the device's measured performance aligns with or exceeds the specified ASTM criteria.
2. Sample size used for the test set and the data provenance
The document specifies "AQL" (Acceptable Quality Level) values for various criteria (e.g., S-2 AQL 4.0, S-4 AQL 4.0, II AQL 1.5). These AQLs are part of a sampling plan that dictates how many units from a lot are inspected and how many defects are allowed before the lot is rejected. The exact sample size for each specific test is not explicitly stated as a numerical value (e.g., "n=100 gloves"). Instead, it refers to the AQL standard, which implies a statistically determined sample size based on lot size and the chosen AQL.
- Sample Size: Not explicitly stated as a number; instead, refers to AQL levels (e.g., S-2 AQL 4.0, S-4 AQL 4.0, II AQL 1.5) which determine sample sizes based on lot size according to ASTM D3578-95.
- Data Provenance: The testing appears to be internal verification against established ASTM standards. The Guinea Pig Sensitization test was performed at "Prince of Songkla University, Department of Pharmacology Faculty of Science" in Thailand, indicating some external testing. The overall nature of the tests (material properties) suggests a retrospective assessment based on manufacturing outputs rather than prospective clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable in the context of this device. The "ground truth" for a patient examination glove is defined by predefined physical and chemical standards (ASTM standard D3578-95), not by expert consensus or interpretation of complex medical data. The tests are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 are used for subjective interpretations (e.g., image reading) where disagreement among experts needs resolution. For objective measurements against specified physical standards, there is no need for expert adjudication.
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
This is not applicable. This is a physical medical device (a glove), not an AI diagnostic or assistive technology. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device. There is no algorithm.
7. The type of ground truth used
The ground truth used is objective, quantifiable physical and chemical standards as defined by ASTM standard D3578-95 for Latex Patient Examination Gloves. Additionally, for biocompatibility, the ground truth for sensitization was based on the results of a Guinea Pig Sensitization (Buehler) test, which is a standard animal model for assessing skin sensitization potential.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of validating a physical product against established performance standards. The product is manufactured and then tested to ensure it meets the specified criteria.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device validation.
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