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Y ADU Surgical Gowns 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 surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB-70.

Device Description

Y ADU Surgical Gowns provide Level 2 and Level 3 protections per ANSI/AAMI PB70 standard.

Y ADU Surgical Gowns (Level 2) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-2 protection.

The Level 2 Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbonded and meltblown polypropyle.

The body and sleeve is made from 35g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 35g Blue SMMS.

Y ADU Surgical Gowns (Reinforced, Level 3) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The chest area is reinforced with layer of PE+SPP material. They provide AAMI Level-3 protection.

The Level 3 Reinforced Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbond and meltblown polypropyle.

The body and sleeve is made from 45g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 45g Blue SMMS. The reinforced area is made from PE +SPP material.

All gowns are sterilized with ethylene oxide.

AI/ML Overview

This document describes the YADU Surgical Gowns (K220092) and their conformance to safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Title of Test	Purpose of Test	Acceptance Criteria	Results (Level 2 gown)	Results (Level 3 gown)
AATCC127: 2018	Water resistance/Hydrostatic Pressure	≥ 20 cm (Level 2)≥ 50 cm (Level 3)	Passed	Passed
AATCC42: 2017	Water Resistance Impact Penetration	≤ 1.0 g	Passed	Passed
ASTM D5034-09	Tensile Strength	MD Mean ≥ 30 N;CD Mean ≥ 30 N	Passed	Passed
ASTM D5733-99	Tearing Strength	MD Mean ≥ 10 N;CD Mean ≥ 10 N	Passed	Passed
ISO 9073-10: 2003	Linting	Average ≤ 10000 (Log L < 4.0)	Passed	Passed
ASTM D1683-17	Seam Strength	≥ 30 N	Passed	Passed
ASTM F1868-17	Evaporative Resistance of Fabrics	No requirement	Passed	Passed
16 CFR 1610	Flammability testing	Meets Requirements Of Flame Resistant CPSC 1610 Class 1	Passed	Passed
ISO 10993-5: 2009	Tests for In vitro cytotoxicity	Under conditions of the study, device extract is not cytotoxic	Passed	Passed
ISO 10993-10: 2010	Tests for irritation And skin	Under the conditions of the study, not an irritant (irritation)	Passed	Passed
ISO 10993-10: 2010	Tests for irritation and skin	Under conditions of the study, not a sensitizer (skin sensitization)	Passed	Passed
ISO 11135: 2014	Sterilization Validation	SAL level of 10-6	Passed	Passed
ISO 11135: 2014 Annex B	Ethylene Oxide residuals	EO: < 4 mg/deviceECH: < 9 mg/device	Passed	Passed

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

The document does not explicitly state the exact sample sizes for each specific test mentioned. However, the tests are non-clinical and conducted to verify design specifications. The data provenance is implied to be from laboratory testing performed by the manufacturer (HeNan YADU Industrial Co., Ltd.) or a testing facility following international standards (e.g., ISO, ASTM, AATCC, CPSC CFR). The tests are retrospective in the sense that they are conducted on manufactured devices to confirm their properties.

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

Not applicable. This device is a surgical gown, and its performance criteria are established by recognized international and national standards (e.g., ANSI/AAMI PB-70, ASTM F2407, ISO 10993, 16 CFR 1610) rather than expert consensus on a test set in the way a diagnostic AI device would. The "ground truth" for each criterion is the objective measurement defined by the respective standard.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation relies on standardized objective test methods rather than subjective human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This is a medical device (surgical gown), not a diagnostic or AI-assisted system for which MRMC studies are typically performed.

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

Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is based on objective measurements and results from standardized laboratory tests according to established national and international consensus standards (e.g., AATCC, ASTM, ISO, CPSC CFR). These standards define the acceptable performance limits for various physical, chemical, and biological properties relevant to surgical gowns.

8. The Sample Size for the Training Set:

Not applicable. As this is a physical medical device and not a machine learning model, there is no "training set" in the context of data used to develop an algorithm. The "development" and "design" of the gown would involve engineering principles and material science, not data training.

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

Not applicable, as there is no training set for this type of device. The design specifications and material selection would be based on existing industry knowledge, material properties, and the requirements of the relevant performance standards.

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