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A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Medi-Grip (Beige 43) Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. Medi-Grip (Beige 43) Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Medi-Grip (Beige 43) Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

This document describes the acceptance criteria and the study proving the device meets those criteria for the Medi-Grip (Beige 43) Surgical Gloves.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the specific performance tests (dimensions, physical properties, freedom from holes, biocompatibility). It only states that the device "meets all of the requirements of ASTM D 3577, Type 1" and "meets all the current specifications for ASTM D 3577 Rubber Surgical Gloves," and also "Meets ASTM D 5151" for freedom from holes. The biocompatibility tests "Passed."

The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from tests conducted to meet U.S. ASTM standards. The data is non-clinical test data. It is considered retrospective in the context of this submission, as the tests were performed prior to the 510(k) submission.

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

Not applicable. For this type of device (surgical gloves), the ground truth is established by standardized performance tests (ASTM standards) with objective measurements, not by expert consensus or interpretation of images. The "experts" involved are presumed to be the appropriately qualified personnel who conduct laboratory testing according to ASTM protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For objective performance tests against pre-defined specifications, multiple readings/tests are typically averaged or analyzed against statistical limits defined by the standard, but there is no "adjudication" in the sense of reconciling differing expert opinions.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are typically used for diagnostic or interpretive devices involving human readers. For surgical gloves, the performance is assessed through objective physical and biocompatibility testing.

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

Yes, the performance evaluation for the Medi-Grip Surgical Gloves is a standalone evaluation of the device itself against established standards. There is no algorithm or human-in-the-loop component for surgical glove performance testing. The "non-clinical tests" (Sections 7 and 8) represent the standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth used is based on pre-defined, objective performance specifications and test methods outlined in industry standards, specifically:

• ASTM D 3577: Standard Specification for Rubber Surgical Gloves
• ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves
• Biocompatibility standards related to primary skin irritation (rabbits) and guinea pig sensitization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept is not relevant to the evaluation of surgical gloves.

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

Not applicable, as there is no training set for this device.

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