Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

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 are provided in sterile. There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

AI/ML Overview

The provided FDA 510(k) summary document (K212869) pertains to Disposable Surgical Gowns. This document describes the acceptance criteria and the study that proves the device meets those criteria, specifically through non-clinical performance testing and biocompatibility assessment rather than studies involving AI algorithms or human readers.

Therefore, many of the requested points regarding AI/human reader studies, ground truth establishment for such studies, and multi-reader multi-case analyses are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides extensive tables (Table 3 and Table 4) detailing the acceptance criteria and results for various non-clinical performance and biocompatibility tests.

Table 1: Summary of Performance Testing - Categorized for clarity

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Flammability	Evaluate flammability of the test sample.	Meets Class 1 requirements	Pass
Hydrostatic Pressure	Determine hydrostatic pressure.	>50 cm	Level 3 Standard Surgical Gown: Average 67cm; Level 4 Standard Surgical Gown: Average 196cm; Level 4 Reinforced Surgical Gown: Average 162cm
Water Impact	Determine hydrostatic pressure. (Note: Description seems to be a typo, likely measuring water penetration/impact resistance)	≤1.0 g	Level 3 Standard Surgical Gown: Average 0.011g; Level 4 Standard Surgical Gown: Average 0.014g; Level 4 Reinforced Surgical Gown: Average 0.017g
Breaking Strength	Evaluate breaking strength.	>20N	Level 3 Standard Surgical Gown: Lat. Avg 96N, Long. Avg 116N; Level 4 Standard Surgical Gown: Lat. Avg 111N, Long. Avg 184N; Level 4 Reinforced Surgical Gown: Lat. Avg 109N, Long. Avg 122N
Tearing Strength	Evaluate tearing strength.	>20N	Level 3 Standard Surgical Gown: Lat. Avg 77N, Long. Avg 128N; Level 4 Standard Surgical Gown: Lat. Avg 90N, Long. Avg 137N; Level 4 Reinforced Surgical Gown: Lat. Avg 80N, Long. Avg 137N
Linting	Evaluate linting.	Log10(particle count) < 4	Level 3 Standard Surgical Gown: Average 3.1; Level 4 Standard Surgical Gown: Average 3.0; Level 4 Reinforced Surgical Gown: Average 3.1
Air Permeability	Evaluate air permeability.	>30 ft³/min/ft²	Level 3 Standard Surgical Gown: Average 40 ft³/min/ft² (Note: Only Level 3 reported, but acceptance criteria imply all gowns with this spec meet it)
EO/ECH Residue	Evaluate level of sterilant residues.	EO: <4mg/device; ECH: <9mg/device (Specific values also provided for each gown type and residue type: <0.5μg/device)	Level 3 Standard Surgical Gown: EO: <0.5μg/device, ECH: <0.5μg/device; Level 4 Standard Surgical Gown: EO: <0.5μg/device, ECH: <0.5μg/device; Level 4 Reinforced Surgical Gown: EO: <0.5μg/device, ECH: <0.5μg/device (All well within acceptance criteria)

Table 2: Summary of Biocompatibility Testing

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Cytotoxicity	Evaluate cytotoxicity.	Viability ≥ 70% of the blank. 50% extract viability should be ≥ 100% extract viability.	Viability ≥ 70% of the blank. 50% extract viability was higher than 100% extract viability. Device was non-cytotoxic.
Sensitization	Evaluate sensitization.	Non-sensitizing	The proposed device was non-sensitizing.
Irritation	Evaluate irritation.	Non-irritating	The proposed device was non-irritating.

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

Sample Size: The document does not explicitly state the specific number of units or samples tested for each non-clinical test. However, it indicates that the tests were performed in accordance with various ASTM, ISO, and AATCC standards, which typically specify appropriate sample sizes for such tests.
Data Provenance: The tests are non-clinical, meaning they are laboratory-based and do not involve patient data. The manufacturer, Fugou County Shenxiang Manufacturing Co., LTD., is located in Henan Province, China. The testing would have been conducted by or overseen by the manufacturer or a third-party testing facility. The data is prospective in the sense that the tests were performed specifically to support this 510(k) submission.

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

Not Applicable. This submission is for surgical gowns, a physical medical device. The "ground truth" for its performance is established through standardized laboratory testing (e.g., barrier properties, strength, flammability) rather than expert consensus on medical images or patient outcomes. The experts involved would be those qualified in materials science, textile engineering, microbiology, and standard compliance, who conduct and interpret the results of these physical and chemical tests.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, the "ground truth" is determined by objective, standardized test protocols, not by expert review or adjudication of subjective interpretations.

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 device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" is defined by objective measurements and performance standards (e.g., ANSI/AAMI PB70:2012, 16 CFR Part 1610, ASTM, and ISO standards) for material properties (hydrostatic pressure, water impact, breaking strength, tearing strength, linting, air permeability) and biological safety (biocompatibility tests like cytotoxicity, irritation, sensitization, and sterilant residues).

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of a physical device like a surgical gown. The product’s design and manufacturing processes are developed to meet the performance criteria, and then tested to confirm compliance.

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

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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, 2021 Fugou County Shenxiang Manufacturing Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K212869

Trade/Device Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA

Dear Diana Hong:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on December 13, 2021. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, Assistant Director of Office of Surgical and Infection Control Devices, at Tel: 301-796-0270 or Email: Clarence.Murrav@fda.hhs.gov.

Sincerely,

Bifeng Qian -S

For Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Fugou County Shenxiang Manufacturing Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K212869

Trade/Device Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: August 19, 2021 Received: September 9, 2021

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 medical devices and radiation-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,

Bifeng Qian -S

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212869

Device Name

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

Indications for Use (Describe)

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

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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K212869

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

1. Date of Preparation: 12/13/2021
1. Sponsor Identification

Fugou County Shenxiang Manufacturing Co., LTD. Industrial Clusters, No.2 Road, Fugou County, Henan Province, China

Establishment Registration Number: 3017149307

Contact Person: Carina Si Position: Business Manager Tel: +86- 21-54889822 Fax: +86- 21-54889180 Email: mike.xu(@fgshenxiang.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (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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Identification of Proposed Device 4.

Trade Name: Disposable Surgical Gown, Disposable Reinforced Surgical 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;

Indication for use:

Device Description:

There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

Table 1. Surgical Gowns Description

Proposed	Model	Size	Color	Style	AAMI	Material
----------	-------	------	-------	-------	------	----------

2 / 13

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device				Level
DisposableSurgicalGown	ML515M45U	S, M, L, XL,XXL,XXXL	Blue	Non-reinforced	3	45g/m² PP SMSnonwoven, Polyester,Blue masterbatch
	GD524ME65	S, M, L, XL,XXL,XXXL	Blue	Non-reinforced	4	45g/m² SMSnonwoven, 20g/m² PEfilm, Polyester, Bluemasterbatch
	DisposableReinforcedSurgicalGown	PA528ME45R	S, M, L, XL,XXL,XXXL	Blue	Reinforced	4

5. Identification of Predicate Devices

Predicate Device 1 510(k) Number: K211422 Product Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown

Predicate Device 2 510(k) Number: K192290 Product Name: SMS Standard Surgical Gown; SMS Surgical Gown with Reinforcement; BVB Surgical Gown; BVB Splicing Surgical Gown

Predicate Device 3 510(k) Number: K121152 Product Name: Surgical Gown

1. Summary of Clinical Testing
  No clinical study is included in this submission.

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7. Summary of Technological characteristics

Item	Proposed Device	Predicate Device K211422	Remark
Product Code	FYA	FYA	Same
Regulation No.	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	Same
Indication for Use	Disposable Surgical Gown andDisposable Reinforced SurgicalGown are intended to be worn byoperating room personnel duringsurgical procedure to protect boththe surgical patient and theoperating room personnel fromtransfer of microorganisms, bodyfluids, and particulate material.Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protective appareland drapes intended for use inhealth care facilities, DisposableSurgical Gown ML515M45U metthe requirements for Level 3classification, Disposable SurgicalGown GD524ME65 andDisposable Reinforced SurgicalGown met the requirements ofLevel 4 classification.	Surgical gown is intended to beworn by operating room personnelduring surgical procedure toprotect both the surgical patientand the operating room personnelfrom transfer of microorganisms,body fluids, and particulatematerial.Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protective appareland drapes intended for use inhealth care facilities, the Level 2standard surgical gowns met therequirements for Level 2classification, the Level 3 standardsurgical gowns and Level 3reinforced surgical gowns met therequirements for Level 3classification.	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 per square (g)	45g/m2	Level 3 Standard Surgical Gown:43g/m²	Different
Size	S, M, L, XL, XXL, XXXL	XS, S, M, L, XL, XXL, XXXL	Different
Flammability	Class I	Class I	Same
Hydrostatic pressure	>50 cm	Level 3 Standard SurgicalGown: >50 cm	Same
Water impact	<1.0 g	<1.0 g	Same

Table 1 Comparison of Technology Characteristics for Level 3 Surgical Gown

4 / 13

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Breaking strength	>20N	>20N	Same
Tearing strength	>20N	>20N	Same
Linting	$Log_{10}<4$	$Log_{10}(particle count) <4$	Same
Air permeability	>30 ft³/min/ft²	>30 ft³/min/ft²	Same
Barrier protectionlevel	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70	Same
Material	SMS, Polyester, Blue masterbatch	Level 3 Standard Surgical Gown:SMS nonwoven, Polyester andPolyamide	Different
Biocompatibility
Cytotoxicity	Under the conditions of the study,	Under the conditions of the study,	Same
Irritation	the device is non-toxic,non-irritating, and	the device is non-toxic,non-irritating, and non-sensitizing.
Sensitization	non-sensitizing.
Sterilization	SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level(SAL): 10-6	SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level(SAL): 10-6	Same

Different - Weight per square

The weight per square for the proposed surgical gowns is different from the predicate device. 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 level 3 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Size

The size for the proposed surgical gowns is different from the predicate device. The proposed surgical gowns are available in 6 product sizes, including S, M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. And the specifications of the proposed device can be covered by the predicated products. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different- Material

The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

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Item	Proposed Device	Predicate Device K192290	Predicate Device K121152	Remark
Product Code	FYA	FYA	FYA	Same
Regulation No.	21CFR 878.4040	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	II	Same
Indication for Use	Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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.	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, SMS Standard Surgical Gown and SMS Surgical Gown with Reinforcement met the requirements for Level 3 classification; BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification.	Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01, are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This product may be sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135.	Same
Style	Non-reinforced/Reinforced	Non-reinforced	Reinforced	Different
Durability	Disposable	Disposable	Disposable	Same
Color	Blue	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
Weight per	Level 4 Standard Surgical	68 g/m²	45 g/m²	Different
square (g)	Gown: 45g/m² and 20g/m²PE filmLevel 4 Reinforced SurgicalGown: 45g/m² and 25g/m²PE film reinforced film
Size	S, M, L, XL, XXL, XXXL	M, L, XL, XXL, XXXL,XXXL-XLONG	XL	Different
Flammability	Class I	Class I	Class I	Same
Hydrostaticpressure	Level 4 Standard SurgicalGown: >50 cm;Level 4 Reinforced SurgicalGown: >50 cm	>50 cm	>20	Same
Water impact	≤1.0 g	≤1.0 g	≤1.0 g	Same
Breaking strength	Level 4 Standard SurgicalGown:latitude: 111 Nlongitude: 184 NLevel 4 Reinforced SurgicalGown:latitude: 109 Nlongitude: 122 N	latitude: 92.3Nlongitude: 177.11N	Passed	Different
Tearing strength	Level 4 Standard SurgicalGown:latitude: 90 Nlongitude: 137 NLevel 4 Reinforced SurgicalGown:latitude: 80 Nlongitude: 137 N	latitude: 35.30Nlongitude: 56.46N	Passed	Different
Linting	Log10<4	Log10<4	Log10<4	Same
BacterialPenetration	No detectable transfer of thePhi-X174 Bacteriophage	No detectable transfer of thePhi-X174 Bacteriophage	No detectable transfer of thePhi-X174 Bacteriophage	Same
Barrier protectionlevel	Level 4 per AAMI PB 70	Level 4 per AAMI PB 70	Level 4 per AAMI PB 70	Same
Material	Level 4 Standard SurgicalGown: SMS nonwoven, PEfilm, Polyester and bluemasterbatch;Level 4 Reinforced SurgicalGown: SMS nonwoven	SMS nonwoven, whiteknitted cuff, whitespunbond, and BVB	SMS and PE+PP two layercompound	Different
	Polyester, PE film reinforcedfilm and Blue masterbatch
Biocompatibility
Cytotoxicity	Under the conditions of thestudy, the device isnon-toxic, non-irritating, andnon-sensitizing.	No CytotoxicityNo IrritationNo Sensitization	Passed	Same
Irritation			Passed
Sensitization			Passed
Sterilization	SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level(SAL): 10-6	Ethylene Oxide (EO)	Although sold non-sterile,gowns can be EO Sterilized	Same

Table 2 Comparison of Technology Characteristics for Level 4 Surgical Gown

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Different - Style

The style of the proposed device is different from the predicate device is available in two styles, non-reinforced and reinforced, which can be covered by predicate device K192290 and reference device K121152. The proposed device offers more options that physician can choose based on clinical conditions. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Weight per square

Although the weight per square of the proposed device and the weight per square of the predicate device are different, 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 level 4 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Size

The size for the proposed surgical gowns is different from the predicate device. The proposed surgical gowns are available in 6 product sizes, including S, 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 longitude and latitude breaking strength of the Level 4 Standard Surgical Gown is larger than that of the predicate device K192290, so it is better than the predicate device. Although the Breaking strength

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of the longitude of the Level 4 Reinforced Surgical Gown is smaller than that of the predicate device K192290, according to EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods, the acceptance criteria of breaking strength shall be more than 20N and the test result for Level 4 Reinforced Surgical Gown can meet this acceptance criteria. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Tearing strength

Although the longitude and latitude tear strength of the proposed device is different from that of the predicate device K192290, the longitude and latitude tear strength of the proposed device is larger than that of predicate device K192290, so the tearing strength is better than that of the predicate device K192290. Therefore, although the data are different, this difference will not affect the safety and effectiveness of the proposed device.

Different - Material

Summary of Non-Clinical Tests 8.

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;
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(2018) 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 F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;

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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;
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
ASTM F1671/F1671M-13 Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens

Name of TestingMethodology	Purpose	AcceptanceCriteria	Results
Flammability	The test was performed inaccordance with 16 CFRPart 1610 Standard for theFlammability of ClothingTextiles to evaluate theflammability of the testsample.	Meets Class 1requirements	Pass
HydrostaticPressure	The test was performed inaccordance with AATCC127: 2017 WaterResistance: HydrostaticPressure Test to determinethe hydrostatic pressure ofthe test sample.	>50 cm	Level 3 Standard SurgicalGown:Average 67cm;Level 4 Standard SurgicalGown:Average 196cm;Level 4 Reinforced SurgicalGown:Average 162cm
Water impact	The test was performed inaccordance with AATCC127: 2017 WaterResistance: HydrostaticPressure Test to determinethe hydrostatic pressure ofthe test sample.	≤1.0 g	Level 3 Standard SurgicalGown:Average 0.011g;Level 4 Standard SurgicalGown:Average 0.014g;Level 4 Reinforced SurgicalGown:Average 0.017g
Breaking strength	The test was performed in	>20N	Level 3 Standard Surgical
	accordance with ASTM D5034:2009(2017) StandardTest Method for BreakingStrength and Elongation ofTextile Fabrics (Grab Test)to evaluate the breakingstrength of the test sample.		Gown:Latitude: average 96N;Longitude: average 116N;Level 4 Standard Surgical

Tearing strength	The test was performed inaccordance with ASTMD5587:2015(2019)Standard Test Method forTearing Strength of Fabricsby Trapezoid Procedure toevaluate the tearingstrength of the test sample.	>20N	Level 4 Standard SurgicalGown:Latitude: average 111N;Longitude: average 184N;Level 4 Reinforced SurgicalGown:Latitude: average 109N;Longitude: average 122N
			Level 3 Standard SurgicalGown:Latitude: average 77N;Longitude: average 128N;Level 4 Standard SurgicalGown:Latitude: average 90N;Longitude: average 137N;Level 4 Reinforced SurgicalGown:Latitude: average 80N;Longitude: average 137N
Linting	The test was performed inaccordance with ISO9073-10:2003 Textiles-TestMethods forNonwovens-Pat 10: Lintand Other ParticlesGeneration in the Dry Stateto evaluate the linting ofthe test sample.	$Log10(particle count) < 4$	Level 3 Standard SurgicalGown:Average 3.1
			Level 4 Standard SurgicalGown:Average 3.0
			Level 4 Reinforced SurgicalGown:Average 3.1
Air permeability	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	Level 3 Standard SurgicalGown:Average 40 ft³/min/ft²
EO/ECH Residue
	The test was performed inaccordance with ISO10993-7:2008 Biologicalevaluation of medicaldevices - Part 7: Ethyleneoxide sterilization residualsto evaluate the level ofsterilant residues.	Level 3 Standard SurgicalGown:EO: <0.5μg/deviceECH: <0.5μg/deviceLevel 4 Standard SurgicalGown:EO: <0.5μg/deviceECH: <0.5μg/deviceLevel 4 Reinforced SurgicalGown:EO: <0.5μg/deviceECH: <0.5μg/device
	EO:<4mg/deviceECH:<9mg/device

Table 3 Summary of Performance Testing

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Table 4 Summary of Biocompatibility Testing

Name of TestingMethodology	Purpose	AcceptanceCriteria	Results
Cytotoxicity	The test was performed inaccordance with ISO10993-5 Third edition2009-06-01 Biologicalevaluation of medicaldevices - Part 5: Tests forin vitro cytotoxicity toevaluate the cytotoxicity ofthe test sample.	Theviabilityshould be $\ge$ 70%of the blank. Andthe 50% extract ofthe test sampleshould have atleast the same or ahigher viabilitythan the 100%extract.	The viability was $\ge$ 70% of theblank. And the 50% extract ofthe test sample had a higherviability than the 100%extract. Under the conditionsof the study, the proposeddevice wasnon-cytotoxic.
Sensitization	The test was performed inaccordance with ISO10993-10 Third Edition2010-08-01 Biologicalevaluation of medicaldevices - Part 10: Tests forirritation and skinsensitization to evaluate thesensitization of the testsample.	Non-sensitizing	Under the conditions of thestudy, the proposed devicewas non-sensitizing.
Irritation	The test was performed inaccordance with ISO10993-10 Third Edition2010-08-01 Biological	Non-irritating	Under the conditions of thestudy, the proposed devicewas non-irritating.

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evaluation of medical
devices - Part 10: Tests for
irritation and skin
sensitization to evaluate the
irritation of the test sample.

9. 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 K211422, K192290 and K121152.

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.