(211 days)
The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex 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® OrthoPro® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove 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 glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features:
- . Slightly Curved Former with Independent/Displaced thumb
- Improved Fit, Feel and Comfort (compared to the current Biogel" Orthopaedic Surgical Glove)
The Molnlycke Healthcare Biogel® OrthoPro® Indicator® Underglove is a disposable natural rubber latex glove intended for use as a barrier against infectious material and contaminants in surgical settings.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria Met? |
|---|---|---|
| Dimensions | Meets ASTM D3577 | Yes |
| Physical Properties | Meets ASTM D3577 | Yes |
| Freedom from Holes | Meets ASTM D3577 | Yes |
| Biocompatibility | Meets ISO 10993-1 | Yes |
| LAL Test Results | Meets ASTM D7102 | Yes |
| Protein Extractables | Meets ASTM D5712 (with a limit of ≤50μg/g total water extractable protein) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (Dimensions, Physical Properties, etc.) nor the provenance of the data (country of origin, retrospective/prospective). It only states that "Performance Data" are summarized, indicating that tests were performed to demonstrate compliance with the listed ASTM and ISO standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The ground truth for this device is based on established scientific and engineering standards (ASTM and ISO), not on expert clinical consensus.
4. Adjudication Method
This information is not applicable as the evaluation is based on objective measurements against defined standards, not on subjective expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The device is a physical barrier (glove), and its performance is evaluated against material and physical property standards, not through clinical comparative effectiveness in a diagnostic or therapeutic context that would involve human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is a physical product (glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
The ground truth used for evaluating the device is based on established scientific and engineering standards (e.g., ASTM D3577 for dimensions, physical properties, and freedom from holes; ISO 10993-1 for biocompatibility; ASTM D7102 for LAL; and ASTM D5712 for protein extractables). These standards define objective criteria and test methods that the device must meet.
8. Sample Size for the Training Set
This information is not applicable. The device is a manufactured product, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a manufactured glove. The "ground truth" for compliance testing is inherent in the internationally recognized and accepted ASTM and ISO standards themselves.
§ 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).