(29 days)
Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility.
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for uses during invasive as well as non-invasive surgical procedures requiring sterlity. They are intended to be worn by operating room personnel to protect a surgical wound from contamination
Ultrafree Plus Powder-Free Surgical gloves are formulated using natural rubber latex and offered sterile.
The provided text describes the safety and effectiveness of Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves. It includes a summary of testing conducted to demonstrate their performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied by standard/regulation) | Reported Device Performance |
|---|---|---|
| Systemic Toxicity | No toxic reactions to acute application | Glove does not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity observed | No reactivity was observed. |
| Guinea Pig Maximization | No potential for irritation | Glove does not display any potential for irritation. |
| Ultimate Elongation & | Meets or exceeds requirements per ASTM D3577-99 | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-99. |
| Tensile Strength | ||
| Barrier Defects | Exceeds requirements per 21 CFR §800.20, AQL = 2.5 | Glove exceeds requirements per 21 CFR §800.20, AQL = 2.5. |
| Residual Powder Level | Less than 4.0 mg per glove (in 1999) | Results generated values below 4 mg of powder residue per glove. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (Systemic Toxicity, Intracutaneous Reactivity, Guinea Pig Maximization, Ultimate Elongation & Tensile Strength, Barrier Defects, Residual Powder Level). These are standard product performance tests for medical devices. The data provenance is derived from testing conducted by the manufacturer, Allegiance Healthcare Sdn. Bhd., as part of their 510(k) submission to the FDA. The tests are retrospective in nature, performed on finished glove products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a surgical glove, and its performance is evaluated through objective physical and biological tests against established standards (e.g., ASTM, FDA regulations, ISO biocompatibility standards). Expert ground truth is not typically established for this type of device performance evaluation.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements and established protocols, not subjective assessment 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 device is a surgical glove and does not involve AI or human readers for its intended use or performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device 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 performance criteria is based on:
- Established industry standards: ASTM D3577-99 for physical properties, ASTM D6124-97 for residual powder.
- FDA regulations: 21 CFR §800.20 for barrier defects (AQL).
- Biocompatibility testing guidelines: Implied for Systemic Toxicity, Intracutaneous Reactivity, and Guinea Pig Maximization, typically following ISO 10993 series or equivalent.
These standards and regulations define the acceptable performance limits for surgical gloves.
8. The sample size for the training set:
Not applicable. This device is a physical product and does not involve machine learning algorithms or training sets.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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).