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The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim is equivalent to the existing model, i.e. Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) Contains 50 Micrograms or Less of Total Water Extractable Protein per gram which had submitted and cleared under 510(k) number K021784. The difference in this submission is: With Aloe Vera coated on surgical gloves.

The provided document describes a medical device, "Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim," and its equivalence to a predicate device. The information presented is for a 510(k) premarket notification and focuses on demonstrating that the modified device meets established standards.

Here's an analysis of the acceptance criteria and study 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 explicitly state the sample sizes used for the tests performed to demonstrate compliance with the acceptance criteria. For instance, it doesn't specify how many gloves were tested for pinholes, dimensions, or physical properties. Similarly, the number of animals (rabbits) used for the biocompatibility tests is not mentioned.

The data provenance is from Malaysia, as stated in the submitter's address: "Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA." The studies appear to be prospective as they were conducted to demonstrate that the modified device meets the specified standards.

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

This information is not provided in the document. The standards (ASTM, FDA regulations) inherently define the "ground truth" for the device's performance characteristics. The tests are designed to measure against these established standards. However, details about the personnel who conducted or validated these tests, or their qualifications, are not included.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable in this context. The document describes standardized tests against predefined criteria (e.g., "Meets ASTM D 3577 - 06"). The results are objective measurements or pass/fail determinations based on these standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation of images or data is involved, often with AI assistance. The device in question is a surgical glove, and its performance is evaluated through physical and chemical property tests, not human interpretation.

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

No, a standalone (algorithm only) performance study was not done. This concept is irrelevant for a surgical glove. The "device performance" refers to the glove's physical and chemical attributes, not an algorithm's output.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and regulatory requirements. Specifically, these include:

• ASTM Standards: Such as ASTM D 3577 - 06 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124 - 06 for powder residual; and ASTM D 5712-99 for protein level.
• FDA Regulations: Specifically 21 CFR 800.20 for freedom from pinholes.
• Biocompatibility Testing: "Primary Skin Irritation in Rabbits" and "Dermal Sensitization" are standard biological evaluation tests designed to determine if a material causes irritation or sensitization.

8. The Sample Size for the Training Set:

This concept is not applicable to this device. A "training set" refers to data used to train a machine learning algorithm. Surgical gloves are physical medical devices, and their performance is assessed through standardized physical and chemical tests, not AI models.

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

This question is not applicable for the same reasons as #8. No training set or machine learning algorithm is involved in the evaluation of this device.

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