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A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

The provided text describes the acceptance criteria and performance of the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves. No study proving the device meets the acceptance criteria is detailed in the submission; rather, the document declares that the device meets existing standards and requirements.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test (e.g., for physical properties, protein content, or biocompatibility). It states that testing was performed according to specific ASTM and ISO standards, which would imply certain sample size requirements within those standards. However, the specific numbers are not reported.

The data provenance is not explicitly stated in terms of country of origin, nor is it explicitly labeled as retrospective or prospective. It is implied to be data collected as part of the device's development and testing for this premarket notification.

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

This information is not applicable to the device described. The device is a surgical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO, CFR) rather than against expert-established ground truth in a diagnostic or interpretive sense. The "ground truth" here is the adherence to these published standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or assessment is involved (e.g., medical image reading). Since this submission concerns a physical medical device (surgical gloves) and its compliance with technical standards, such adjudication methods are not relevant or described. The tests are objective measurements against defined criteria.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or interpretive devices where human readers are involved. For surgical gloves, the evaluation focuses on meeting predefined physical and biochemical standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical product, not an algorithm, so a standalone study in this context is irrelevant.

7. Type of Ground Truth Used

The "ground truth" used is defined by adherence to established industry and regulatory standards. Specifically:

• ASTM D3577 (for dimensions, physical properties, freedom from holes, powder residual)
• 21 CFR 800.20 (for AQL in freedom from holes)
• ASTM D6124 (for testing powder residual)
• ASTM D5712 (for protein content)
• FDA Medical Glove Guidance Manual (for protein content)
• ISO 10993-1 (for biocompatibility)
• ISO 10993-10 (for primary skin irritation and guinea pig maximization)

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI/ML algorithm that requires a training set.

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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