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Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification.

Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.

The Surgical Gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relabler for further packaging and Ethylene Oxide (EO) sterilization.

The subject device includes six models, which are provided in Table 1 Model List. The six models have the same product size, the only difference is whether the surgical gown has an inside reinforcement and material of the reinforcement. AG1001 and AE1001 don't have the reinforcement. AG2001 and AE2001 have an inside trapezoidal fabric-reinforcement on the chest and two sleeves of the gown. AG3001 and AE3001 have an inside rectangular poly-reinforcement on the chest and two sleeves of the gown.

The document is a 510(k) summary for GMAX Industries, Inc.'s Surgical Gown (AE and AG series). It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison of the subject device (GMAX Surgical Gown) with two predicate devices (Medline Eclipse™ Surgical Gown and Disposable Surgical Gowns by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.). The table highlights several physical and mechanical specifications as acceptance criteria and reports the subject device's performance against these criteria, or states "Not known" for predicate devices.

Note on Acceptance Criteria: The document primarily uses the predicate devices' characteristics and recognized standards (like AAMI PB70) as benchmarks for "acceptance criteria." For some parameters, the subject device's specific performance values are presented as meeting these underlying standards or being "large enough for safety using" even when predicate values are unknown.

2. Sample Sizes and Data Provenance

The document explicitly states: "No clinical study is included in this submission."

Therefore, information regarding sample size for test sets, data provenance (e.g., country of origin, retrospective/prospective) for a clinical study is not applicable as no clinical study was conducted. The testing was non-clinical.

3. Number of Experts and Qualifications

This information is not applicable. Since no clinical study was performed and no human performance evaluation (e.g., diagnostic accuracy) was part of this submission, there was no need for experts to establish ground truth for a test set.

4. Adjudication Method

This information is not applicable for the same reasons as above.

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

This information is not applicable. No MRMC study was conducted. The submission is for a medical device (surgical gown) and focuses on physical and biological testing, not on comparative effectiveness for diagnosis or treatment involving human readers.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The device is a surgical gown, not an algorithm or AI system.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference standards used are established test methods from recognized standards organizations. These include:

• AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes
• ASTM D737-04 (2016) Standards Test Method for Air Permeability of Textile Fabrics
• 16 CFR 1610: 2008 Standard for the Flammability of Clothing Textiles
• AATCC 127:2003 Water Resistance: Hydrostatic Pressure Test
• AATCC 42:2007 Water Resistance: Impact Penetration Test
• ISO 9073-10:2003 Textiles- Test Method for Nonwovens- Part 10: Lint and Other Particles Generation in the Dry State
• ASTM D1683-11 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
• ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
• ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in vitro Cytotoxicity
• ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization

These standards define the methodologies and expected outcomes for each test.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product (surgical gown), not a software or AI model that requires a "training set."

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

This information is not applicable for the same reasons as above.

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