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.

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.

Device Description

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.

AI/ML Overview

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:

Test Methodology	Test Purpose	Acceptance Criteria	Reported Device Performance
Flammability	Evaluate flammability per 16 CFR Part 1610.	Meets Class 1 requirements	Class 1
Hydrostatic pressure	Determine hydrostatic pressure per AATCC 127:2017.	Level 2 Surgical Gown: >20 cm H2O; Level 3 Surgical Gown: >50 cm H2O; AQL 4.0	Level 2 Standard Surgical Gown: PASS; Level 3 Standard Surgical Gown: PASS; Level 3 Standard Plus Surgical Gown: PASS; Level 3 Reinforced Surgical Gown: PASS; Level 3 Reinforced Plus Surgical Gown: PASS
Water impact	Determine water resistance (impact penetration) per AATCC 42:2017.	<1.0 g; AQL 4.0	Level 2 Standard Surgical Gown: PASS; Level 3 Standard Surgical Gown: PASS; Level 3 Standard Plus Surgical Gown: PASS; Level 3 Reinforced Surgical Gown: PASS; Level 3 Reinforced Plus Surgical Gown: PASS
Breaking strength	Evaluate breaking strength per ASTM D5034:2009(2017).	≥30N	Level 2 Standard Surgical Gown: MACHINE DIRECTION:101.4N, CROSS DIRECTION:66.6N; Level 3 Standard Surgical Gown: MACHINE DIRECTION:101.4N, CROSS DIRECTION:66.6N; Level 3 Standard Plus Surgical Gown: MACHINE DIRECTION:107.7N, CROSS DIRECTION:61.6N; Level 3 Reinforced Surgical Gown: MACHINE DIRECTION:101.4N, CROSS DIRECTION:66.6N; Level 3 Reinforced Plus Surgical Gown: MACHINE DIRECTION:120.0N, CROSS DIRECTION:101.1N
Tearing strength	Evaluate tearing strength per ASTM D5587:2015(2019).	≥10N	Level 2 Standard Surgical Gown: MACHINE DIRECTION:36.0N, CROSS DIRECTION:21.5N; Level 3 Standard Surgical Gown: MACHINE DIRECTION:35.9N, CROSS DIRECTION:22.8N; Level 3 Standard Plus Surgical Gown: MACHINE DIRECTION:44.1N, CROSS DIRECTION:30.8N; Level 3 Reinforced Surgical Gown: MACHINE DIRECTION:36.0N, CROSS DIRECTION:21.5N; Level 3 Reinforced Plus Surgical Gown: MACHINE DIRECTION:45.9N, CROSS DIRECTION:28.8N
Seam strength	Evaluate seam strength per ASTM D1683/D1683M:2017(2018).	≥30N	Level 2 Standard Surgical Gown: Average 37.4N; Level 3 Standard Surgical Gown: Average 36.9N; Level 3 Standard Plus Surgical Gown: Average 111.8N; Level 3 Reinforced Surgical Gown: Average 37.5N; Level 3 Reinforced Plus Surgical Gown: Average 116.1N
Linting	Evaluate linting per ISO 9073-10:2003.	Log10(particle count) < 4	Level 2 Standard Surgical Gown: Average 2.97; Level 3 Standard Surgical Gown: Average 2.97; Level 3 Standard Plus Surgical Gown: Average 2.94; Level 3 Reinforced Surgical Gown: Average 2.97; Level 3 Reinforced Plus Surgical Gown: Average 2.99
Air permeability	Evaluate air permeability per ASTM D737: 2018.	>30 ft³/min/ft² (>15 cm³/s/cm²)	Level 2 Standard Surgical Gown: Average 40.55 ft³/min/ft² (20.60 cm³/s/cm²); Level 3 Standard Surgical Gown: Average 33.85 ft³/min/ft² (17.20 cm³/s/cm²); Level 3 Standard Plus Surgical Gown: Average 32.68 ft³/min/ft² (16.60 cm³/s/cm²); Level 3 Reinforced Surgical Gown: Average 40.55 ft³/min/ft² (20.60 cm³/s/cm²); Level 3 Reinforced Plus Surgical Gown: Average 34.84 ft³/min/ft² (17.70 cm³/s/cm²)
Cytotoxicity	Evaluate cytotoxicity per ISO 10993-5:2009.	Viability ≥70% of blank; 50% extract viable at or higher than 100% extract.	The viability was ≥70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic.
Sensitization	Evaluate skin sensitization per ISO 10993-10:2010.	Non-sensitizing	Under the conditions of the study, the proposed device was non-sensitizing.
Irritation	Evaluate irritation per ISO 10993-10:2010.	Non-irritating	Under the conditions of the study, the proposed device was non-irritating.
Sterilization validation	Validate sterilization process (Ethylene Oxide) per ISO 11135 for both sterile and non-sterile configurations	Sterile Assurance Level (SAL): 10^-6	Sterilization process for the proposed device has been validated per ISO 11135 and the result demonstrated that sterilization method is valid.

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 21, 2022

Xuchang Zhengde Environstar Medical Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China

Re: K213893

Trade/Device Name: Comfort Gown, Safewear Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: November 22, 2022 Received: November 30, 2022

Dear Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Allan Guan -S

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213893

Device Name Comfort Gown, Safewear Gown

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K213893

1. Date of Preparation: 12/20/2022
1. Sponsor Identification

Xuchang Zhengde Environstar Medical Products Co., Ltd.

Area B, Baihua Road East, South Side of Erji river, Industry Cluster District, Yanling County, 461200 Xuchang, Henan, CHINA

Establishment Registration Number: 3009114792

Contact Person: Vincent Yu Position: Regulatory Engineer Tel: +86-18658510660 Email: yjf(@zhende.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Comfort Gown, Safewear Gown Common Name: Surgical Gown

Regulatory Information

Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;

Indications for use:

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. 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

Device Description:

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.

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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.

Proposeddevice	Type	Size	Style	AAMILevel
ComfortGown	Level 1 Standard Surgical Gown	M, L, XL, XXL, XXXL	Non-reinforced	1
ComfortGown	Level 2 Standard Surgical Gown	M, L, XL, XXL, XXXL	Non-reinforced	2
ComfortGown	Level 3 Standard Surgical Gown	M, L, XL, XXL, XXXL	Non-reinforced	3
SafewearGown	Level 3 Standard Plus Surgical Gown	M, L, XL, XXL, XXXL	Non-reinforced	3
SafewearGown	Level 3 Reinforced Surgical Gown	M, L, XL, XXL, XXXL	Reinforced	3
SafewearGown	Level 3 Reinforced Plus Surgical Gown	M, L, XL, XXL, XXXL	Reinforced	3

Specification of Surgical Gown Table1

1. Identification of Predicate Devices
1. Predicate Device 1

510(k) Number: K192290

Product Name: SMS Standard Surgical Gown, SMS Surgical Gown with Reinforcement, BVB Surgical Gown, BVB Splicing Surgical Gown

Predicate Device 2 510(k) Number: K172987 Product Name: Surgical Gown (used AE series as predicate device)

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;

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AATCC 42: 2017 Water Resistance: Impact Penetration Test; >
ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
ASTM D1683/D1683M: 2017 Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
ASTM D5587:2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics;
ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
A ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
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;

TestMethodology	Test Purpose	Acceptance Criteria	Results
Flammability	The test was performed inaccordance with 16 CFRPart 1610 Standard for theFlammability of ClothingTextiles to evaluate theflammability of the testsample.	Meets Class1requirements	Class 1
Hydrostaticpressure	The test was performed inaccordance with AATCC127:2017 WaterResistance HydrostaticPressure Test to determinethe hydrostatic pressure ofthe test sample.	Level 2 SurgicalGown: >20 cm H2O;Level 3 SurgicalGown: >50 cm H2O;AQL 4.0	Level 2 Standard SurgicalGown: PASS;Level 3 Standard SurgicalGown: PASS;Level 3 Standard PlusSurgical Gown: PASS;Level 3 ReinforcedSurgical Gown: PASS;Level 3 Reinforced PlusSurgical Gown: PASS
Water impact	The test was performed in	<1.0 g	Level 2 Standard Surgical
	accordance with AATCC42:2017 Water resistance:impact penetration test todetermine the hydrostaticpressure of the test sample.	AQL 4.0	Gown: PASS;Level 3 Standard SurgicalGown: PASS;Level 3 Standard PlusSurgical Gown: PASS;Level 3 ReinforcedSurgical Gown: PASS;Level 3 Reinforced PlusSurgical Gown: PASS;
Breakingstrength	The test was performed inaccordance with ASTM D5034:2009(2017) StandardTest Method for BreakingStrength and Elongation ofTextile Fabrics (Grab Test)to evaluate the breakingstrength of the test sample	≥30N	Level 2 Standard SurgicalGown:MACHINEDIRECTION:101.4NCROSSDIRECTION:66.6NLevel 3 Standard SurgicalGown:MACHINEDIRECTION:101.4NCROSSDIRECTION:66.6NLevel 3 Standard PlusSurgical Gown:MACHINEDIRECTION:107.7NCROSSDIRECTION:61.6NLevel 3 ReinforcedSurgical Gown:MACHINEDIRECTION:101.4NCROSSDIRECTION:66.6NLevel 3 Reinforced PlusSurgical Gown:MACHINEDIRECTION:120.0NCROSSDIRECTION:101.1N
Tearing	The test was performed in	≥10N	Level 2 Standard Surgical
strength
	accordance with ASTMD5587:2015(2019)Standard Test Method forTearing Strength ofFabrics by TrapezoidProcedure to evaluate thetearing strength of the testsample.		Gown:MACHINEDIRECTION:36.0NCROSSDIRECTION:21.5NLevel 3 Standard SurgicalGown:MACHINEDIRECTION:35.9NCROSSDIRECTION:22.8NLevel 3 Standard PlusSurgical Gown:MACHINEDIRECTION:44.1NCROSSDIRECTION:30.8NLevel 3 ReinforcedSurgical Gown:MACHINEDIRECTION:36.0NCROSSDIRECTION:21.5NLevel 3 Reinforced PlusSurgical Gown:MACHINEDIRECTION:45.9NCROSSDIRECTION:28.8N
Seamstrength	The test was performed inaccordance with ASTMD1683/D1683M:2017(2018) Standard TestMethod for Failure inSewn Seams of WovenFabrics to evaluate theseam strength of the testsample.	≥30N	Level 2 Standard SurgicalGown:Average 37.4N;Level 3 Standard SurgicalGown:Average 36.9N;Level 3 Standard PlusSurgical Gown:Average 111.8N;Level 3 ReinforcedSurgical Gown:

			Average 37.5N;
			Level 3 Reinforced PlusSurgical Gown:
			Average 116.1N
Linting	The test was performed inaccordance with ISO9073-10:2003Textiles-Test Methods forNonwovens-Pat 10: Lintand Other ParticlesGeneration in the DryState to evaluate the lintingof the test sample.	Log10(particlecount) < 4	Level 2 Standard SurgicalGown:Average 2.97;Level 3 Standard SurgicalGown:Average 2.97;Level 3 Standard PlusSurgical Gown:Average 2.94;Level 3 ReinforcedSurgical Gown:Average 2.97;Level 3 Reinforced PlusSurgical Gown:Average 2.99
Airpermeability	The test was performed inaccordance with ASTMD737: 2018 Standard TestMethod for AirPermeability of TextileFabrics to evaluate the airpermeability of the testsample.	>30 ft³/min/ft²(>15 cm³/s/cm²)	Level 2 Standard SurgicalGown:Average 40.55 ft³/min/ft²(20.60 cm³/s/cm²);Level 3 Standard SurgicalGown:Average 33.85 ft³/min/ft²(17.20 cm³/s/cm²);Level 3 Standard PlusSurgical Gown:Average 32.68 ft³/min/ft²(16.60 cm³/s/cm²);Level 3 ReinforcedSurgical Gown:Average 40.55 ft³/min/ft²(20.60 cm³/s/cm²);Level 3 Reinforced PlusSurgical Gown:Average 34.84 ft³/min/ft²(17.70 cm³/s/cm²)
Test Method	Purpose	Acceptance Criteria	Results
Cytotoxicity	The test was performed in accordancewith ISO 10993-5 Third edition2009-06-01 Biological evaluation ofmedical devices - Part 5: Tests for invitro cytotoxicity to evaluate thecytotoxicity of the test sample.	The viability shouldbe ≥70% of theblank. And the 50%extract of the testsample should haveat least the same or ahigher viability thanthe 100% extract.	The viability was ≥70%of the blank. And the50% extract of the testsample had a higherviability than the 100%extract.Under the conditions ofthe study, the proposeddevice wasnon-cytotoxic.
Sensitization	The test was performed in accordancewith ISO 10993-10 Third Edition2010-08-01 Biological evaluation ofmedical devices - Part 10: Tests forirritation and skin sensitization toevaluate the sensitization of the testsample.	Non-sensitizing	Under the conditions ofthe study, the proposeddevice wasnon-sensitizing.
Irritation	The test was performed in accordancewith ISO 10993-10 Third Edition2010-08-01 Biological evaluation ofmedical devices - Part 10: Tests forirritation and skin sensitization toevaluate the irritation of the testsample.	Non-irritating	Under the conditions ofthe study, the proposeddevice was non-irritating.

Summary of Performance Testing Table2

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Table3 Summary of Biocompatibility Testing

8. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Summary of Technological characteristics

Table4 General Comparison for Comfort Gown			Remark
Item	Proposed DeviceK213893	Predicate Device 2K172987
Product Code	FYA	FYA	Same
RegulationNo.	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	Same
Indication forUse	Surgical gown is intended to be wornby operating room personnel duringsurgical procedure to protect both thesurgical patient and the operatingroom personnel from transfer ofmicroorganisms, body fluids, andparticulate material.	Surgical gown is intended to be wornby operating room personnel duringsurgical procedure to protect both thesurgical patient and the operating roompersonnel from transfer ofmicroorganisms, body fluids, andparticulate material.	Same
	Per ANSI/AAMI PB70:2012 Liquidbarrier performance and classificationof protective apparel and drapesintended for use in health carefacilities, the comfort gown met therequirements for Level 2classification.	Per ANSI/AAMI PB70:2012 Liquidbarrier performance and classificationof protective apparel and drapesintended for use in health carefacilities, the AE series surgical gownsmet the requirements for Level 2classification.	Same
Style	Non-reinforced	Non-reinforced/Reinforced	Different
Durability	Disposable	Disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
Weight persquare (g)	35g/m²	44g/m²	Different
Size	M, L, XL, XXL, XXXL	XL	Different
Flammability	Class I	Class I	Same
Hydrostaticpressure	>20 cm;	AE series: >20 cm;	Same
Water impact	≤1.0 g	≤1.0 g	Same
Breakingstrength	≥30N	>20N	Different
Tearingstrength	≥10N	>30N	Different
Seam	≥30N	≥30N	Same

	Table4 General Comparison for Comfort Gown
--	----------------------------------------------------

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strength
Linting	$Log_{10}≤4$	$Log_{10}≤4$	Same
Airpermeability	>30 ft³/min/ft²	>30 ft³/min/ft²	Same
Barrierprotectionlevel	Level 1/Level 2 per AAMI PB 70	Level 2 per AAMI PB 70	Different
Material	SMS nonwoven, Polyester, Polyamide;	SMMMS, Polypropylene,Polyethylene, Polyester	Different
Cytotoxicity	Under the conditions of the study, the	Under the conditions of the study, the
Irritation	device is non-toxic, non-irritating, and	device is non-toxic, non-irritating, and	Same
Sensitization	non-sensitizing.	non-sensitizing.
Sterilization	Sterile/Non-SterileSterile Method: Ethylene Oxide (EO);Sterilization Assurance Level (SAL):10-6	Non-sterile	Different

Different - Weight per square

The weight per square for the proposed surgical gowns is different from the predicate device K172987. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70. Therefore, this difference will not raise any safety issues.

Different - Size

The size for the proposed surgical gowns is different from the predicate device K172987. The proposed surgical gowns are available in 5 product sizes, including M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Breaking Strength

The breaking strength for the proposed surgical gowns is different from the predicate device K172987, however, the breaking strength of the proposed device is large than the predicate device. It can be considered that the proposed device showed a better performance to resist breaking. Therefore, this difference will not raise any safety issues.

Different - Tearing strength

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The tearing strength for the proposed surgical gowns is different from the predicate device K172987, the tearing strength of the proposed device is less than the predicate device. The proposed acceptance criteria not less than 10N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.

Different - Barrier protection level

The barrier protection level of proposed device is not same as the predicate device K172987, the proposed Comfort Gown is available in level 2 two protection levels. These two levels gowns are exactly same and classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons. The level 2 can be covered by the predicate device K172987. Although the level 1 is not covered by the predicate device K172987, since the proposed level 2 gowns are same, therefore, this difference will not raise any safety issues. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70.

Different - Material

The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility for proposed device was evaluated and the results showed no adverse effect. Therefore, this difference will not raise any safety issues.

Different - Sterilization

The product status of the proposed device is different from the predicate device. The proposed device can be provided in sterile and non-sterile, and the predicate device is non-sterilized. However, although the predicate device is non-sterile, it shall be further sterilized prior to use. In addition, sterilization process for the proposed device has been validated per ISO 11135 and the result demonstrated that sterilization method is valid. Therefore, this difference will not raise any safety issues.

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Item	Proposed DeviceK213893	Predicate Device 1K192290	Remark
Product Code	FYA	FYA	Same
RegulationNo.	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	Same
Indication forUse	Surgical gown is intended to be wornby operating room personnel duringsurgical procedure to protect both thesurgical patient and the operatingroom personnel from transfer ofmicroorganisms, body fluids, andparticulate material.	Surgical gown is intended to be wornby operating room personnel duringsurgical procedure to protect both thesurgical patient and the operating roompersonnel from transfer ofmicroorganisms, body fluids, andparticulate material.	Same
	Per ANSI/AAMI PB70:2012 Liquidbarrier performance and classificationof protective apparel and drapesintended for use in health carefacilities, the Level 3 StandardSurgical Gown and level 3 StandardPlus Surgical Gown met therequirements for Level 3classification.	Per ANSI/AAMI PB70:2012 Liquidbarrier performance and classificationof protective apparel and drapesintended for use in health carefacilities, SMS Standard SurgicalGown and SMS Surgical Gown withReinforcement met the requirementsfor Level 3 classification.	Same
Style	Non-reinforced	Non-reinforced	Same
Durability	Disposable	Disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
Weight persquare (g)	$45g/m^2 +50 g/m^2, 50g/m^2;$	$50g/m^2$	Different
Size	M, L, XL, XXL, XXXL	M, L, XL, XXL, XXXL,XXXL-XLONG	Different
Flammability	Class I	Class I	Same
Hydrostaticpressure	>50 cm;	>50 cm	Same
Water impact	≤1.0 g	≤1.0 g	Same
Breakingstrength	≥30N	cross direction: 61.17Nmachine direction: 107.35N	Different
Tearing	>10N	cross direction: 19.71N	Different

Table5 General Comparison for level 3 standard surgical gown & level 3 standard plus
surgical gown of Safewear Gown

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strength		machine direction: 62.28N
Seam strength	≥30N	≥30N	Same
Linting	Log10<4	Log10<4	Same
Air permeability	>30 ft³/min/ft²	>30 ft³/min/ft²	Same
Barrier protection level	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70	Same
Material	SMS nonwoven, Polyester, Polyamide;	SMS nonwoven, Polyester, Polyamide;	Same
Cytotoxicity	Under the conditions of the study, the	Under the conditions of the study, the	Same
Irritation	device is non-toxic, non-irritating, and	device is non-toxic, non-irritating, and
Sensitization	non-sensitizing.	non-sensitizing.
Sterilization	Sterile/Non-SterileSterile Method: Ethylene Oxide (EO);Sterilization Assurance Level (SAL): 10-6	SterileSterile Method: Ethylene Oxide (EO);Sterilization Assurance Level (SAL): 10-6	Different

Different - Weight per square

The weight per square for the proposed surgical gowns is different from the predicate device K19290. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70. Therefore, this difference will not raise any safety issues.

Different - Size

The size for the proposed surgical gowns is different from the predicate device K192290. The proposed surgical gowns are available in 5 product sizes, including M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Breaking Strength

The breaking strength for the proposed surgical gowns is different from the predicate device K192290. The proposed acceptance criteria not less than 30N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.

Different - Tearing strength

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The tearing strength for the proposed surgical gowns is different from the predicate device K192290, the tearing strength of the proposed device is less than the predicate device. The proposed acceptance criteria not less than 10N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.

Different - Sterilization

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Item	Proposed Device	Predicate Device 1	Remark
	K213893	K192290
Product Code	FYA	FYA	Same
RegulationNo.	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	Same
Indication forUse	Surgical gown is intended to be wornby operating room personnel duringsurgical procedure to protect both thesurgical patient and the operatingroom personnel from transfer ofmicroorganisms, body fluids, andparticulate material.Per ANSI/AAMI PB70:2012 Liquidbarrier performance andclassification of protective appareland drapes intended for use in healthcare facilities, the Level 3Reinforced Surgical Gown and Level3 reinforced plus surgical gown metthe requirements for Level 3classification.	Surgical gown is intended to be worn byoperating room personnel duringsurgical procedure to protect both thesurgical patient and the operating roompersonnel from transfer ofmicroorganisms, body fluids, andparticulate material.Per ANSI/AAMI PB70:2012 Liquidbarrier performance and classification ofprotective apparel and drapes intendedfor use in health care facilities, SMSStandard Surgical Gown and SMSSurgical Gown with Reinforcement metthe requirements for Level 3classification.	Same
Style	Reinforced	Reinforced	Same
Durability	Disposable	Disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
Weight persquare (g)	$45 g/m^2$ , $35g/m^2$	$45g/m^2$	Different
Size	M, L, XL, XXL, XXXL	M, L, XL, XXL, XXXL, XXXL-XLONG	Different
Flammability	Class I	Class I	Same
Hydrostaticpressure	>50 cm;	>50 cm	Same
Water impact	≤1.0 g	≤1.0 g	Same
Breakingstrength	≥30N	cross direction: 81.90Nmachine direction: 110.44N	Different
Tearing	>10N	cross direction: 25.32N	Different
strength		machine direction: 45.3N
Seam strength	≥30N	≥30N	Same
Linting	Log10<4	Log10<4	Same
Airpermeability	>30 ft³/min/ft²	>30 ft³/min/ft²	Same
Barrierprotectionlevel	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70	Same
Material	SMS nonwoven, Polyester, Polyamide, LOCTITE LIOFOL LA 3720, PE breathable film;	SMS nonwoven, Polyester, Polyamide, LOCTITE LIOFOL LA 3720, PE breathable film;	Same
Cytotoxicity	Under the conditions of the study, the device is non-toxic,	Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing.	Same
Irritation	non-irritating, and non-sensitizing.
Sensitization
Sterilization	Sterile/Non-SterileSterile Method: Ethylene Oxide (EO);Sterilization Assurance Level (SAL): 10-6	SterileSterile Method: Ethylene Oxide (EO);Sterilization Assurance Level (SAL): 10-6	Different

General Comparison for level 3 reinforced surgical gown & Level 3 reinforced Table6 plus surgical gown of Safewear Gown

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Different - Weight per square

The weight per square for the proposed surgical gowns is different from the predicate device K19299. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70. Therefore, this difference will not raise any safety issues.

Different - Size

Different - Breaking Strength

The breaking strength for the proposed surgical gowns is different from the predicate device K19299. The proposed acceptance criteria not less than 30N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.

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Different - Tearing strength

Different – Sterilization

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10. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate devices K172987 and K192290.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.