(46 days)
The Biogel® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The proposed device, the Biogel® PI OrthoPro® Brown Surgical Glove is manufactured of non-latex (polyisoprene) colored with brown pigmentation. The Biogel® Pl OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years. The differences in the proposed glove and the predicate are as follows:
- Addition of a Brown Colorant .
- Thicker Glove .
- New Former .
The glove former design used in the manufacture of this glove allows the Biogel® PI OrthoPro® Brown Surgical Glove to provide the user with this additional feature: - Slightly Curved Former with Independent/Displaced thumb ●
Here's an analysis of the acceptance criteria and supporting study for the Biogel® PI OrthoPro® Brown Surgical Glove:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from ASTM D3577 & 21 CFR 800.20) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Non-irritating | Gloves are non-irritating. |
| ISO Closed Patch Sensitization | 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 Properties | Meet requirements for rubber surgical gloves per ASTM D3577 | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Exceed requirements of 21 CFR 800.20 and ASTM D3577 | Gloves exceed the requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Below 2mg of residual powder per glove (for "Powder-Free" designation per ASTM D3577 using ASTM D6142) | Results generated values below 2mg of residual powder per glove. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., how many gloves were tested for freedom from holes or dimensions). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The general phrasing "Results generated values" suggests data collection was performed to derive these values.
3. Number of Experts and Qualifications for Ground Truth
This device is a surgical glove, which falls under Class I medical devices and undergoes performance testing against established standards (ASTM, CFR). There is no indication that human expert review for establishing "ground truth" (in the typical sense of diagnostic imaging or clinical assessment) was required or used in these performance tests. The ground truth for these tests is defined by the objective metrics and thresholds within the cited ASTM and CFR standards.
4. Adjudication Method
Not applicable. As noted above, the assessment relies on objective measurement against predefined standards, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not relevant for a surgical glove. MRMC studies are typically used to evaluate the effectiveness of diagnostic devices or AI algorithms in clinical decision-making with human readers.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical product (surgical glove), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
The ground truth used for these performance tests is based on established industry standards and regulatory requirements, specifically:
- ASTM D3577: Standard Specification for Rubber Surgical Gloves.
- 21 CFR 800.20: Regulations related to barrier integrity for gloves (implied for "Freedom from Holes").
- ASTM D6142: Standard Test Method for Residual Powder on Medical Gloves.
These standards define the acceptable physical properties, dimensions, and integrity requirements for surgical gloves.
8. Sample Size for the Training Set
Not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The manufacturing process and quality control would involve ongoing testing and process adjustments, but not a dataset used for AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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).