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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, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications.

The gowns are provided sterile and non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

The proposed devices are 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. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile.

There are two types of surgical gown: Comfort Gown and Safewear Gown. And each type of surgical gown is available in five product sizes, including M, L, XL, XXL and XXXL.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Comfort Gown include Level 1 standard surgical gown which met the requirements for Level 1 classification, and Level 2 standard surgical gown which met the requirements for Level 2 classification. It is made of the same material and is classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons.

Safewear gown include Level 3 standard surgical gown, Level 3 standard plus surgical gown, Level 3 reinforced surgical gown and Level 3 reinforced plus surgical gown, which all met the requirements for AAMI Level 3. The four Level 3 surgical gowns differ in the weight of non-woven and whether there are reinforcements, which is 45g/m² and 50g/m² for Level 3 standard surgical gown, 50g/m² for Level 3 standard plus surgical gown, 35g/m² for Level 3 reinforced surgical gown with 35g/m² PE breathable film reinforcement and 45g/m2 for Level 3 reinforced plus surgical gown with 35g/m² PE breathable film reinforcement.

The provided text is a 510(k) Summary for surgical gowns (Comfort Gown, Safewear Gown). It details non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

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 each specific non-clinical test. It lists the tests performed and their results for the different types of gowns (Comfort Gown and Safewear Gown, across various levels and styles).

The data provenance is non-clinical testing, performed by the manufacturer (Xuchang Zhengde Environstar Medical Products Co., Ltd.) to specific international and national standards (e.g., AATCC, ASTM, ISO, CFR). The country of origin of the data is implied to be China, given the manufacturer's address. The data is prospective in the sense that these tests were conducted specifically for the submission to demonstrate compliance.

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

This information is not applicable as the acceptance criteria are based on pre-defined objective performance standards (e.g., cm H2O for hydrostatic pressure, N for breaking strength, etc.), not expert consensus on qualitative data. The "ground truth" here is the pass/fail against these quantifiable benchmarks.

4. Adjudication Method for the Test Set:

This is not applicable as the tests are objective, quantitative measurements against established standards, not subjective assessments requiring adjudication.

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:

This is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

This is not applicable. The device is a physical product (surgical gown), not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on established standard specifications and quantifiable measurements (e.g., physical properties like strength, barrier performance, and biological safety evaluations). This is analogous to "bench testing" or "laboratory outcomes data" for medical devices, rather than expert consensus, pathology, or clinical outcomes data in the context of diagnostic algorithms.

8. The Sample Size for the Training Set:

This is not applicable. The context is non-clinical performance testing of a physical medical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

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