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Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare persomel to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.

The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/A AMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).

The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.

The Donagamex Blue Performance Protective Gown is a Class II medical device under the FDA product code QPC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Donagamex Blue Performance Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Donagamex Blue Performance Protective Gowns are non-woven, blue gowns, available in various sizes and have no areas of reinforcement. They are made from a layer of polyethylene laminated over spun-bonded polypropylene and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a protective gown. The Donagamex Blue Performance Protective Gown is a single use, disposable medical device that will be sold non-sterile.

The provided text is related to the 510(k) premarket notification for a medical device: "Donagamex Blue Performance Protective Gown" (K203821). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" largely refers to the non-clinical performance tests conducted to ensure the protective gown meets specific standards for barrier protection, material strength, flammability, and biocompatibility.

Here's a breakdown of the information as it can be extracted from the document, tailored to the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

Note: ASTM - D3776:2020 (Mass Per Unit Area) and ISO 9073-10 (Lint & other Particles Generation) were listed with purpose but "N/A" for acceptance criteria and results in the provided table, suggesting they were likely characterization tests rather than tests against specific acceptance thresholds for clearance in this context.

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

• Sample Size for Barrier Performance: For the AAMI PB70:2012 liquid barrier testing, the document states: "Testing was performed using 3 nonconsecutive lots and 32 samples per lot in each critical zone area." This means a total of 96 samples (3 lots * 32 samples/lot) were tested per critical zone (chest, back, and sleeve seam).
• Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the manufacturer is "Dong Nai Garment Corporation" located in Vietnam. The tests are referenced against international and US standards (AATCC, ASTM, ISO, CFR). The timeframe implies these tests were conducted retrospectively for the 510(k) submission.

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

• Not applicable for this type of device and study. This device is a protective gown, and the performance evaluation relies on standardized physical, chemical, and biological testing methods rather than expert interpretation of images or clinical outcomes. The "ground truth" is established by the test methods themselves and their defined pass/fail criteria.

4. Adjudication Method for the Test Set

• Not applicable. As the device is characterized by objective physical and material properties assessed via standardized tests, there is no human interpretation or adjudication process involved in the test results.

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

• Not applicable. This section is relevant for AI/ML-driven diagnostic devices that assist human readers (e.g., radiologists). The "Donagamex Blue Performance Protective Gown" is a Class II surgical apparel, not an AI/ML diagnostic device, and therefore, no MRMC study was conducted or is relevant. The study performed is a non-clinical performance study against established material and barrier standards.

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

• Not applicable. As explained above, this device is not an algorithm or AI system. Its performance is entirely standalone in terms of its physical properties. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties without human interaction beyond conducting the test protocol.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective, standardized test methods and their defined performance criteria (e.g., AAMI PB70:2012 for liquid barrier, ASTM standards for material strength, CPSC 1610 for flammability, and ISO 10993 for biocompatibility). These are physical and biological measurements against pre-defined thresholds.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this device does not involve machine learning or AI models that require data for training. The product is manufactured and then tested to ensure it meets performance specifications.

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

• Not applicable. As there is no training set, there is no corresponding ground truth establishment process for it. The "ground truth" for demonstrating substantial equivalence and device performance is established through adherence to recognized consensus standards for material testing and barrier properties.

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