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The Biogel® 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 Biogel® Indicator™ Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

This 510(k) summary describes the Biogel® Indicator™ Underglove, a sterile powder-free latex surgical glove. The device is classified as a Class I surgical glove (CFR 878.4461).

Here's an analysis of the provided information covering the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size used for testing each characteristic. Given that the compliance is stated as "Meets ASTM D3577" and "Meets ISO 10993-1," it is understood that standard testing protocols for these specifications would have been followed, which inherently include defined sample sizes for each test. For example, ASTM D3577 specifies sampling plans for inspection of dimensions, physical properties, and freedom from holes.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, as these are technical performance tests against established standards (ASTM, ISO), the testing would typically be performed in a laboratory setting under controlled conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For performance tests against established industry standards (ASTM D3577, ISO 10993-1), the "ground truth" is the standard itself. These standards define objective, measurable criteria. Therefore, the concept of "experts establishing ground truth" in the same way as, for example, diagnostic image interpretation, does not directly apply here.

The "experts" involved would be the laboratory technicians and qualified personnel who conduct the tests according to the standard procedures and interpret the results against the specified limits. Their qualifications would include training and certification in performing these specific ASTM and ISO tests.

4. Adjudication Method for the Test Set

Adjudication methods like '2+1' or '3+1' are typically used for subjective assessments (e.g., medical image interpretation consensus). Since the device's performance is measured against objective, quantitative standards (ASTM D3577, ISO 10993-1, LAL test), an adjudication method in this context does not apply. The test results are either within the specified limits of the standard or they are not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The device is a surgical glove, and the evaluation focuses on its physical properties, biocompatibility, and barrier integrity as defined by objective standards, not on human interpretive tasks that would benefit from an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical product (a surgical glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is established industry and international standards (ASTM D3577, ISO 10993-1), along with the specific product claim for protein content (50 micrograms or less) and endotoxin concentration (<0.25 EU/ml). These are objective, measurable criteria.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an AI model or software algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As stated above, there is no "training set" for this type of device submission.

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