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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. (Table of chemotherapy drugs and breakthrough times) Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes

This is a disposable polyisoprene surqical glove that is tested for use with chemotherapy drugs and fentanyl. The device is composed of two layers which are not attached in the fingers or palm/back of hand region, but are attached in the cuff area. The outer layer of the glove is white and the inner layer is green. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 81/2 and 9, and is provided sterile. No shelf life is claimed.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This document is a 510(k) premarket notification for a medical device (surgical gloves), which primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device. Therefore, many of the questions related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable (N/A) in this context.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many gloves were tested for tensile strength or dimensional analysis). It refers to standard test methods (e.g., ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11, ASTM D6978-05), which inherently define the required sample sizes for conducting those tests to achieve statistically valid results according to their respective standards. The data provenance is Malaysia, as the submitter (WRP Asia Pacific Sdn. Bhd.) is located in Malaysia. The testing is retrospective, conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This device's performance is established through objective, standardized physical and chemical testing, not expert interpretation of cases or images.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers, where there's subjectivity in interpretation. This is not relevant for the objective physical and chemical tests performed on the surgical gloves.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is not an AI-assisted device. The device itself is a surgical glove.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an algorithm or AI-based device.

7. The type of ground truth used

The "ground truth" for the performance of the surgical gloves is established by objective measurements against established industry standards and regulatory requirements. For example:

• Physical Properties: Measured tensile strength, elongation, and stress values are compared against minimum/maximum thresholds defined by ASTM D3577 and D412.
• Dimensions: Measured lengths, widths, and thicknesses are compared against specified ASTM D3577 requirements for each glove size.
• Watertightness: The number of detected holes is compared against the Acceptable Quality Limit (AQL) of 1.5 as per ASTM D5151 and D3577.
• Residual Powder: The measured powder residue is compared against the limit of ≤2.0 mg/glove as per ASTM D6124 and D3577.
• Biocompatibility: Biological responses (irritation, sensitization, systemic toxicity, pyrogenicity) are evaluated against the criteria for "Pass" as defined by ISO 10993-10 and ISO 10993-11.
• Chemotherapy Drug Permeation and Fentanyl Resistance: The breakthrough detection times are measured according to ASTM D6978 and compared against established timeframes.

8. The sample size for the training set

N/A. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

N/A. Not applicable as there is no training set for this device.

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