(108 days)
These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
Sterile Latex Powder-Free Surgical gloves are formulated using natural rubber latex. They are coated with nitrile coating and are offered powder-free and sterile. The gloves are brown in color.
The provided document is a 510(k) summary for "Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating". This document describes the device, its intended use, and substantial equivalence to a predicate device, along with performance testing results.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Non-irritating | Gloves are non-irritating. |
| Guinea Pig Maximization | No potential for sensitization | Gloves do not display any potential for sensitization. |
| Dimensions | Meet requirements of ASTM D3577 | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics | Meet requirements for rubber surgical gloves per ASTM D3577 | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Meet requirements of 21 CFR 800.20 and ASTM D3577 | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Below 2mg of residual powder per glove (for "Powder-Free") | Results generated values below 2mg of residual powder per glove, meeting "Powder-Free" designation per ASTM D3577 (tested using ASTM D6124). |
| Protein Content | Less than 50 µg/dm² of total water extractable protein per glove | Yielded the results of less than 50 µg/dm² of total water extractable protein per glove (tested in accordance with ASTM D5712). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes used for each test on the gloves (e.g., how many gloves were tested for freedom from holes or dimensions). The data provenance is generally from testing conducted by or for Cardinal Healthcare 222 LTD. in Thailand, as it's the manufacturer. The tests are "prospective" in the sense that they were conducted for the purpose of demonstrating device performance for this submission, rather than being retrospective analysis of existing data.
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 standardized physical, chemical, and biological tests, not through expert interpretation of data like medical imaging. The "ground truth" for these tests are the established standards (e.g., ASTM D3577, 21 CFR 800.20, ASTM D6124, ASTM D5712).
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is determined by meeting defined physical and biological specifications, not through expert adjudication of ambiguous results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Surgical gloves are not typically evaluated using MRMC studies, as they are not diagnostic devices that involve human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (surgical glove), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on established industry standards and regulatory requirements, such as:
- ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
- 21 CFR 800.20 (Listing of device by type and manufacturer) - for freedom from holes
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D5712 (Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Isoprene Latex)
- Biological safety endpoints for skin irritation and sensitization.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set". The term "training set" refers to data used to train an algorithm. For a physical device like a glove, there is no such concept.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as point 8.
§ 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).