(86 days)
These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination.
The Duraprene Sterile Synthetic Surgical Gloves are formulated using neoprene and offered sterile.
This document describes the acceptance criteria and the summary of testing conducted for the Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "requirements" mentioned in the "Summary of Testing" section, primarily referencing ASTM D3577-91 and 21 CFR §800.20.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intracutaneous Reactivity | No irritation following intradermal injection of extracts. | Glove does not elicit irritation following intradermal injection of extracts. |
| Kligman Maximization Sensitization | No potential to produce skin sensitization. | Glove does not display potential to produce skin sensitization. |
| USP Mouse Systemic Test | No systemic response. | No systemic response was observed. |
| Ultimate Elongation & Tensile Strength | Meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects | Meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5 and ASTM D3577-91, AQL=1.5. | Glove meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5 and ASTM D3577-91, AQL=1.5. |
| Powder Level | Meets powder level requirements for "Powder Free" designation (below 2mg/glove cornstarch level). | Gloves meet powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2mg/glove cornstarch level including. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. For "Ultimate Elongation & Tensile Strength" and "Barrier Defects," the reference to ASTM D3577-91 and 21 CFR §800.20 would imply standard sampling methods as defined by these regulations and standards. The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it can be inferred that these are in-house laboratory tests conducted by the manufacturer as part of the 510(k) submission process.
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 tests performed are primarily objective laboratory and biological evaluations, not requiring expert consensus for ground truth establishment in the way a diagnostic imaging device might.
4. Adjudication method for the test set
Not applicable. The tests are primarily objective measurements or biological assessments, not subjective interpretations requiring 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
Not applicable. This is a medical device (surgical glove) and not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the tests is based on:
- Established standards: ASTM D3577-91 for mechanical properties and barrier defects, and 21 CFR §800.20 for barrier defects.
- Biological reactivity assays: Standardized tests like Intracutaneous Reactivity, Kligman Maximization Sensitization, and USP Mouse Systemic Test, which have defined endpoints for "no irritation," "no sensitization," and "no systemic response."
- Chemical analysis: For powder level, a vacuum filtration method combined with a negative iodine test against a defined threshold of 2mg/glove cornstarch.
8. The sample size for the training set
Not applicable. This is a physical medical device, and the concept of "training set" is not relevant in this context. The manufacturing process and quality control systems ensure consistency, rather than a data-driven training process.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for a physical device like a surgical glove. Quality control and adherence to manufacturing specifications ensure the product meets its intended design.
§ 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).