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Ultralon® Powder Free Latex Surgical Gloves are to be worn by operating room personnel to protect a surgical wound from contamination.

Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.

This report describes the acceptance criteria and study proving the performance of Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify a separate "test set" in the context of clinical trials as clinical data were deemed not needed. The product's performance was evaluated against established ASTM standards through non-clinical testing. The sample sizes for these non-clinical tests (e.g., for dimensions, physical properties, freedom from holes, biocompatibility, and protein content) are not explicitly stated in this summary. The data provenance is non-clinical laboratory testing performed by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable, as the acceptance criteria are based on established ASTM standards and non-clinical laboratory testing, not on expert consensus from clinicians for a specific test set.

4. Adjudication Method for Test Set

Not applicable. The evaluation was based on meeting pre-defined ASTM standards through laboratory testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data are not needed for medical gloves or for most devices cleared by the 510(k) process."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical product (surgical glove), not an algorithm or a device with an AI component requiring standalone algorithm performance evaluation.

7. Type of Ground Truth Used

The "ground truth" for the device's performance relies on:

• Established ASTM Standards: For dimensions, physical properties, freedom from holes (ASTM D 3577-00 and ASTM D 5151-99).
• Established Biocompatibility Tests: Guinea Pig Sensitization and Primary Skin Irritation in Rabbits.
• Established ASTM Standard for Protein Analysis: ASTM D 5712-99 for the protein label claim.

8. Sample Size for Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device evaluated against pre-defined standards, not a machine learning model.

9. How Ground Truth for Training Set Was Established

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

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