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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization to ISO 11135-1.

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 and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.

The proposed devices are available in two materials, SMMS and BVB. SMMS surgical gowns are available in three gram weights, 35g/m², 43g/m², while BVB surgical gown is available only in 64g/m². All SMMS surgical gowns are provided in two types, standard and reinforced. And all types of SMMS surgical gown and BVB surgical gown are available in six product sizes, including M, L, LL, XL, XLL and XXL.

The barrier protection level for 35g Standard SMMS Surgical Gown meet AAMI Level 2; The barrier protection level for 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown meet AAMI Level 3; The barrier protection level for BVB Surgical gown meet AAMI Level 4.

AI/ML Overview

The provided text describes the non-clinical testing of surgical gowns to demonstrate their substantial equivalence to predicate devices, rather than a study for an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria, performance, ground truth, experts, and training/test set details cannot be extracted from this document.

However, I can provide the acceptance criteria and performance results for the physical properties and biocompatibility of the surgical gowns based on the provided tables.

1. A table of acceptance criteria and the reported device performance

Test Methodology	Acceptance Criteria	Reported Device Performance
Flammability	Meets Class 1 requirements	Class 1
Hydrostatic pressure	Level 2 Surgical Gown: >20 cm H2O; Level 3 Surgical Gown: >50 cm H2O; Level 4 Surgical Gown: >50 cm H2O	35g Standard SMMS Surgical Gown: (Non-sterile): Average 40.57cm; (Sterile): Average 40.21cm (Meets Level 2) 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 83.53cm; (Sterile): Average 83.57cm (Meets Level 3) 43g Standard SMMS Surgical Gown: (Non-sterile): Average 60.50 cm; (Sterile): Average 60.48 cm (Meets Level 3) 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 99.59 cm; (Sterile): Average 98.90 cm (Meets Level 3) 50g Standard SMMS Surgical Gown: (Non-sterile): Average 83.19 cm; (Sterile): Average 83.02 cm (Meets Level 3) 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 108.37 cm; (Sterile): Average 108.37 cm (Meets Level 3) BVB Surgical Gown: (Non-sterile): Average 161.71 cm; (Sterile): Average 162.11 cm (Meets Level 4)
Water impact	≤1.0 g	35g Standard SMMS Surgical Gown: (Non-sterile): Average 0.041g; (Sterile): Average 0.03g 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.03g; (Sterile): Average 0.029g 43g Standard SMMS Surgical Gown: (Non-sterile): Average 0.036g; (Sterile): Average 0.033g 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.032g; (Sterile): Average 0.032g 50g Standard SMMS Surgical Gown: (Non-sterile): Average 0.031g; (Sterile): Average 0.034g 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.033g; (Sterile): Average 0.031g BVB Surgical Gown: (Non-sterile): Average 0.078g; (Sterile): Average 0.079g (All meet criteria)
Breaking strength	≥30N	35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 108.37N; Longitude: 161.87N; (Sterile): Latitude: 108.37N; Longitude: 161.87N 35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 108.72N; Longitude: 161.19N; (Sterile): Latitude: 108.53N; Longitude: 161.31N 43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 113.34N; Longitude: 182.30N; (Sterile): Latitude: 113.01N; Longitude: 181.05N 43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 113.72N; Longitude: 181.14N; (Sterile): Latitude: 112.60N; Longitude: 181.26N 50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 137.58N; Longitude: 190.87N; (Sterile): Latitude: 137.77N; Longitude: 188.30N 50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 138.02N; Longitude: 191.32N; (Sterile): Latitude: 138.39N; Longitude: 190.07N BVB Surgical Gown: (Non-sterile): Latitude: 148.44N; Longitude: 236.60N; (Sterile): Latitude: 148.93N; Longitude: 237.72N (All values significantly greater than 30N)
Tearing strength	≥10N	35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 32.49N; Longitude: 39.67N; (Sterile): Latitude: 32.31N; Longitude: 39.81N 35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 32.44N; Longitude: 39.67N; (Sterile): Latitude: 32.55N; Longitude: 39.92N 43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 33.99N; Longitude: 41.40N; (Sterile): Latitude: 33.92N; Longitude: 41.75N 43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 34.09N; Longitude: 41.51N; (Sterile): Latitude: 34.01N; Longitude: 41.18N 50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 44.02N; Longitude: 54.18N; (Sterile): Latitude: 44.36N; Longitude: 54.07N 50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 43.93N; Longitude: 53.96N; (Sterile): Latitude: 44.30N; Longitude: 54.25N BVB Surgical Gown: (Non-sterile): Latitude: 49.76N; Longitude: 53.97N; (Sterile): Latitude: 49.23N; Longitude: 53.98N (All values significantly greater than 10N)
Linting	Log10(particle count) < 4	35g Standard SMMS Surgical Gown: (Non-sterile): Average 2.89; (Sterile): Average 2.89 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 2.89; (Sterile): Average 2.90 43g Standard SMMS Surgical Gown: (Non-sterile): Average 2.50; (Sterile): Average 2.47 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 2.47; (Sterile): Average 2.54 50g Standard SMMS Surgical Gown: (Non-sterile): Average 2.50; (Sterile): Average 2.51 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 2.47; (Sterile): Average 2.48 BVB Surgical Gown: (Non-sterile): Average 2.54; (Sterile): 2.52 (All meet criteria)
Seam strength	≥30N	35g Standard SMMS Surgical Gown: (Non-sterile): Average 41.90N; (Sterile): Average 42.21N 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 41.75N; (Sterile): Average 41.74N 43g Standard SMMS Surgical Gown: (Non-sterile): Average 44.51N; (Sterile): Average 44.56N 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 44.55N; (Sterile): Average 44.34N 50g Standard SMMS Surgical Gown: (Non-sterile): Average 50.52N; (Sterile): Average 50.45N 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 50.45N; (Sterile): Average 50.57N BVB Surgical Gown: (Non-sterile): 70.27N; (Sterile): 70.35N (All values significantly greater than 30N)
Air permeability	≥30 ft³/min/ft²	35g Standard SMMS Surgical Gown: (Non-sterile): Average 70.65 ft³/min/ft²; (Sterile): Average 68.89 ft³/min/ft² 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 70.67 ft³/min/ft²; (Sterile): Average 69.94 ft³/min/ft² 43g Standard SMMS Surgical Gown: (Non-sterile): Average 65.05 ft³/min/ft²; (Sterile): Average 65.51 ft³/min/ft² 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 65.76 ft³/min/ft²; (Sterile): Average 66.56 ft³/min/ft² 50g Standard SMMS Surgical Gown: (Non-sterile): Average 62.03 ft³/min/ft²; (Sterile): Average 62.15 ft³/min/ft² 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 62.12 ft³/min/ft²; (Sterile): Average 62.06 ft³/min/ft² (All meet criteria)
Viral barrier (resistance to bacteriophage Phi-X174)	No bacteriophage penetration	For BVB Surgical Gowns only: No bacteriophage penetration (Meets criteria)
Ethylene Oxide Residuals	EO:<4mg/device; ECH:<9mg/device	EO Residue: 0.84 mg/device; ECH Residue: 1.18 mg/device (Both meet criteria)
Cytotoxicity	Viability $\ge$ 70% of the blank; 50% extract of test sample should have at least same or higher viability than 100% extract	The viability was $\ge$ 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. (Meets criteria)
Sensitization	Non-sensitizing	Under the conditions of the study, the proposed device was non-sensitizing. (Meets criteria)
Irritation	Non-irritating	Under the conditions of the study, the proposed device was non-irritating. (Meets criteria)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each test. Instead, it reports average values. It does not provide information on the country of origin of the data or whether the tests were retrospective or prospective, beyond stating that "Non clinical tests were conducted to verify that the proposed device met all design specifications".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as this document pertains to physical and biocompatibility testing of a medical device (surgical gowns), not an AI/ML diagnostic or assistive device that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., imaging reads) to establish ground truth. The tests described here are laboratory-based objective measurements.

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 section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML diagnostic or assistive device.

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

This section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the physical and biocompatibility tests are the established international and national standards and methodologies (e.g., 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 10993-5, etc.) against which the device's performance is measured. For instance, flammability "ground truth" is meeting Class 1 requirements, hydrostatic pressure "ground truth" is a minimum cm H2O value, and cytotoxicity "ground truth" is cell viability $\ge$ 70% of the blank.

8. The sample size for the training set

This section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML device.

9. How the ground truth for the training set was established

This section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.

September 19, 2022

Winner Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co, Ltd. P.O. Box 120-119 Shanghai, 200120 China

Re: K221819

Trade/Device Name: 35g Standard Surgical Gown; 35g Reinforced SMMS Surgical Gown; 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: May 18, 2022 Received: June 23, 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

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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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K221819

Device Name

35g Standard SMMS Surgical Gown, 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown, 50g Reinforced SMMS Surgical Gown, BVB Surgical Gown

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

|X 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: K221819

1. Date of Preparation: 09/19/2022
1. Sponsor Identification

Winner Medical Co., Ltd.

Winner Industrial Park, No.660 Bulong Road, Longhua District, Shenzhen Guangdong, China 518109

Establishment Registration Number: 9616433

Contact Person: Mingni Liu Position: Regulatory Affairs Tel: +86-755-28138888-8822 Email: 2346@winnermedical.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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4. Identification of Proposed Device

Trade Name: 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown: 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB 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

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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.

Device Description:

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and are provided in sterile and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.

Proposed device	Size	Gram weight	Color	Style	AAMI Level	Sterilization
35g Standard SMMS Surgical Gown	M, L, LL, XL, XLL, XXL	35 g/m²	Blue	Standard	2	Sterile/Non-sterile
35g Reinforced SMMS Surgical Gown	M, L, LL, XL, XLL, XXL	35 g/m²	Blue	Reinforced	3	Sterile/Non-sterile
43g Standard SMMS Surgical Gown	M, L, LL, XL, XLL, XXL	43 g/m²	Blue	Standard	3	Sterile/Non-sterile
43g Reinforced SMMS Surgical Gown	M, L, LL, XL, XLL, XXL	43 g/m²	Blue	Reinforced	3	Sterile/Non-sterile
50g Standard SMMS Surgical Gown	M, L, LL, XL, XLL, XXL	50 g/m²	Blue	Standard	3	Sterile/Non-sterile
50g Reinforced SMMS Surgical Gown	M, L, LL, XL, XLL, XXL	50 g/m²	Blue	Reinforced	3	Sterile/Non-sterile
BVB Surgical Gown	M, L, LL, XL, XLL, XXL	64 g/m²	Blue	Standard	4	Sterile/Non-sterile

Table 1. Specification

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ડ. Identification of Predicate Devices

Predicate Device 1 510K Number: K211422 Trade Name: Level 2 Standard Surgical Gown Level 3 Standard Surgical Gown Level 3 Reinforced Surgical Gown

Predicate Device 2 510K Number: K192290 Trade Name: SMS Standard Surgical Gown SMS Surgical Gown with Reinforcement BVB Surgical Gown (used as predicate device 2) BVB Splicing Surgical Gown

Summary of Technological characteristics 6.

Item	Proposed DeviceK221819	Predicate Device 1K211422	Remark
ProductName	35g Standard SMMS Surgical Gown,35g Reinforced SMMS Surgical Gown,43g Standard SMMS Surgical Gown,43g Reinforced SMMS Surgical Gown,50g Standard SMMS Surgical Gown,50g Reinforced SMMS Surgical Gown	Level 2 Standard Surgical Gown,Level 3 Standard Surgical Gown, /Level 3 Reinforced Surgical Gown
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 operating roompersonnel from transfer ofmicroorganisms, body fluids, andparticulate material.	Surgical gown is intended to beworn by operating room personnelduring surgical procedure to protectboth the surgical patient and theoperating room personnel fromtransfer of microorganisms, bodyfluids, and particulate material.	Same
	Per ANSI/AAMI PB70:2012 Liquid	Per ANSI/AAMI PB70:2012 Liquid

Table 2. General Comparison for SMMS Surgical Gown

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	barrier performance and classification of protective apparel and drapes intended for use in health care facilities, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification.	barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
Style	Standard/Reinforced	Non-reinforced/Reinforced	Same
Use	Single use, disposable	Single use, disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same

Table 3. Safety and Effectiveness Comparison for SMMS Surgical Gown

Item	Proposed DeviceK221819	Predicate Device 1K211422	Remark
Product Name	35g Standard SMMS Surgical Gown,35g Reinforced SMMS Surgical Gown,43g Standard SMMS Surgical Gown,43g Reinforced SMMS Surgical Gown,50g Standard SMMS Surgical Gown,50g Reinforced SMMS Surgical Gown	Level 2 Standard Surgical Gown,Level 3 Standard Surgical Gown, /Level 3 Reinforced Surgical Gown
Weightpersquare (g)	35g Standard SMMS Surgical Gownand 35g Reinforced SMMS SurgicalGown: 35g/m²43g Standard SMMS Surgical Gownand 43g Reinforced SMMS SurgicalGown: 43g/m²50g Standard SMMS Surgical Gownand 50g Reinforced SMMS SurgicalGown: 50g/m²	Level 2 Standard Surgical Gown:35g/m²Level 3 Standard Surgical Gown:43g/m²Level 3 Reinforced Surgical Gown:35g/m² and 28g/m²	Different
Size	M, L, LL, XL, XLL, XXL	XS, S, M, L, XL, XXL, XXXL	Different
Flammability	Class I	Class I	Same
Hydrostaticpressure	35g Standard SMMS Surgical Gown(Non-sterile): Average 40.57cm;	Level 2 Standard SurgicalGown: >20 cm;	Different
	35g Standard SMMS Surgical Gown	Level 3 Standard Surgical
	(Sterile): Average 40.21cm;	Gown: >50 cm;
	35g Reinforced SMMS Surgical Gown	Level 3 Reinforced Surgical
	(Non-sterile): Average 83.53cm;	Gown: >50 cm
	35g Reinforced SMMS Surgical Gown(Sterile): Average 83.57cm;
	43g Standard SMMS Surgical Gown(Non-sterile): Average 60.50 cm;
	43g Standard SMMS Surgical Gown(Sterile): Average 60.48 cm;
	43g Reinforced SMMS Surgical Gown(Non-sterile): Average 99.59 cm;
	43g Reinforced SMMS Surgical Gown(Sterile): Average 98.90 cm;
	50g Standard SMMS Surgical Gown(Non-sterile): Average 83.19 cm;
	50g Standard SMMS Surgical Gown(Sterile): Average 83.02 cm;
	50g Reinforced SMMS Surgical Gown(Non-sterile): Average 108.37 cm;
	50g Reinforced SMMS Surgical Gown(Sterile): Average 108.37 cm;
Water impact	35g Standard SMMS Surgical Gown(Non-sterile): Average 0.041g;	≤1.0 g	Different
	35g Standard SMMS Surgical Gown(Sterile): Average 0.03g;
	35g Reinforced SMMS Surgical Gown(Non-sterile): Average 0.03g;
	35g Reinforced SMMS Surgical Gown(Sterile): Average 0.029g;
	43g Standard SMMS Surgical Gown(Non-sterile): Average 0.036g;
	43g Standard SMMS Surgical Gown(Sterile): Average 0.033g;
	43g Reinforced SMMS Surgical Gown(Non-sterile): Average 0.032g;
	43g Reinforced SMMS Surgical Gown(Sterile): Average 0.032g;
	50g Standard SMMS Surgical Gown(Non-sterile): Average 0.031g;
Breakingstrength	50g Standard SMMS Surgical Gown (Sterile): Average 0.034g;50g Reinforced SMMS Surgical Gown (Non-sterile): Average 0.033g50g Reinforced SMMS Surgical Gown (Sterile): Average 0.031g35g Standard SMMS Surgical Gown (Non-sterile):Latitude: 108.37N;Longitude: 161.87N;35g Standard SMMS Surgical Gown (Sterile):Latitude: 108.37NLongitude: 161.87N;35g Reinforced SMMS Surgical Gown (Non-sterile):Latitude: 108.72NLongitude: 161.19N;35g Reinforced SMMS Surgical Gown (Sterile):Latitude: 108.53NLongitude: 161.31N;
	43g Standard SMMS Surgical Gown (Non-sterile):Latitude: 113.34NLongitude: 182.30N;43g Standard SMMS Surgical Gown (Sterile):Latitude: 113.01NLongitude: 181.05 N;43g Reinforced SMMS Surgical Gown (Non-sterile):Latitude: 113.72NLongitude: 181.14 N;43g Reinforced SMMS Surgical Gown (Sterile):Latitude: 112.60NLongitude: 181.26N;50g Standard SMMS Surgical Gown (Non-sterile):	>20N	Different
Tearingstrength	Latitude: 137.58NLongitude: 190.87 N;50g Standard SMMS Surgical Gown(Sterile):Latitude: 137.77NLongitude: 188.30 N;50g Reinforced SMMS Surgical Gown(Non-sterile):Latitude: 138.02NLongitude: 191.32N;50g Reinforced SMMS Surgical Gown(Sterile):Latitude: 138.39NLongitude: 190.07 N;35g Standard SMMS Surgical Gown(Non-sterile):Latitude: 32.49 NLongitude: 39.67 N;35g Standard SMMS Surgical Gown(Sterile):Latitude: 32.31NLongitude: 39.81N;35g Reinforced SMMS Surgical Gown(Non-sterile):Latitude: 32.44NLongitude: 39.67N;35g Reinforced SMMS Surgical Gown(Sterile):Latitude: 32.55NLongitude: 39.92N;43g Standard SMMS Surgical Gown(Non-sterile):Latitude: 33.99NLongitude: 41.40N;43g Standard SMMS Surgical Gown(Sterile):Latitude: 33.92NLongitude: 41.75N;43g Reinforced SMMS Surgical Gown(Non-sterile)	>20N	Different
	Latitude: 34.09NLongitude: 41.51;43g Reinforced SMMS Surgical Gown(Sterile):Latitude: 34.01NLongitude: 41.18N;50gStandard SMMS Surgical Gown(Non-sterile):Latitude: 44.02NLongitude: 54.18N;50g Standard SMMS Surgical Gown(Sterile):Latitude: 44.36NLongitude: 54.07N;50g Reinforced SMMS Surgical Gown(Non-sterile):Latitude: 43.93NLongitude: 53.96N;50g Reinforced SMMS Surgical Gown(Sterile):Latitude: 44.30NLongitude: 54.25N;35g Standard SMMS Surgical Gown(Non-sterile): Average 41.90N35g Standard SMMS Surgical Gown(Sterile): Average 42.21N35g Reinforced SMMS Surgical Gown(Non-sterile): Average 41.75N35g Reinforced SMMS Surgical Gown(Sterile): Average 41.74N43g Standard SMMS Surgical Gown(Non-sterile): Average 44.51N43g Standard SMMS Surgical Gown(Sterile): Average 44.56N43g Reinforced SMMS Surgical Gown(Non-sterile): Average 44.55N43g Reinforced SMMS Surgical Gown(Sterile): Average 44.34N50g Standard SMMS Surgical Gown(Non-sterile): Average 50.52N	>30N	Different
Seam strength
50g Standard SMMS Surgical Gown(Sterile): Average 50.45N50g Reinforced SMMS Surgical Gown(Non-sterile): Average 50.45N50g Reinforced SMMS Surgical Gown(Sterile): Average 50.57N
Linting	Log10(particle count) <4	Log10(particle count) <4	Same
Airpermeability	>30 ft³/min/ft²	>30 ft³/min/ft²	Same
Barrierprotectionlevel	Level 2 and 3 per AAMI PB 70	Level 2 and 3 per AAMI PB 70	Same
Material	Standard SMMS Surgical Gown:Non-woven SMMS Fabric, Polyester,Mixing polyester with nylonReinforced SMMS Surgical Gown:Non-woven SMMS Fabric, Polyester,Mixing polyester with nylon, PP andPE fabric	Level 2 Standard Surgical Gownand Level 3 Standard SurgicalGown: SMS nonwoven, Polyesterand Polyamide;Level 3 Reinforced Surgical Gown:SMS nonwoven, Polyester,Polyamide and Hydrophilicnonwoven	Different
Biocompatibility
Cytotoxicity	Under the conditions of the study, the	Under the conditions of the study,
IrritationSensitization	device is non-toxic, non-irritating, andnon-sensitizing.	the device is non-toxic,non-irritating, and non-sensitizing.	Same
Sterilization	Sterile/Non-sterileSterile Method: Ethylene Oxide (EO);Sterilization Assurance Level (SAL):10-6	SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level(SAL): 10-6	Different
EthyleneOxideResiduals	EO:<4mg/deviceECH:<9mg/device	EO:<4mg/deviceECH:<9mg/device	Same

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Different - Weight per square

The weight per square for the proposed device is different from the predicate device K211422. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed devices 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

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The size for the proposed device is different from the predicate device K211422. The proposed devices are available in 6 product sizes, including M, L, LL, XL, XL, XLL and XXL. 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 - Hydrostatic pressure

The hydrostatic pressure for the proposed device is different from the predicate device K211422. However, the hydrostatic pressure test has been conducted on the proposed device and the results demonstrate that the proposed devices 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 - Water impact

The water impact for the proposed device is different from the predicate device K211422. However, the water impact test has been conducted on the proposed device and the results demonstrate that the proposed devices 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 - Breaking strength

The breaking strength for the proposed device is different from the predicate device K211422. However, the breaking strength test was conducted on the proposed device and the testing results demonstrate that the breaking strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Tearing strength

The tearing strength for the proposed device is different from the predicate device K211422. However, the tearing strength test was conducted on the proposed device and the testing results demonstrate that the tearing strength of the proposed device meets ASTM F2407-20's requirement of greater than 10N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Seam strength

The seam strength for the proposed device is different from the predicate device K211422. However, the seam strength test was conducted on the proposed device and the testing results demonstrate that the seam strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Material

The material for the proposed device is different from the predicate device K211422. 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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Different - Sterilization

The proposed devices are available in two sterilization states, sterile and non-sterile, while the predicate device K211422 is only available in sterilized state. However, the non-sterilized surgical gown is required to be used after sterilization, and the recommended sterilization parameters for non-sterilized surgical gowns are the same as sterilized surgical gowns. The performance test report after sterilization shows that the proposed device is acceptable. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Item	Proposed DeviceK221819	Predicate Device 2K192290	Remark
ProductName	BVB Surgical Gown	BVB Surgical Gown	/
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 operating roompersonnel from transfer ofmicroorganisms, body fluids, andparticulate material.Per ANSI/AAMI PB70:2012 Liquidbarrier performance and classificationof protective apparel and drapesintended for use in health carefacilities, BVB Surgical gown met therequirements for Level 4 classification.	Surgical gown is intended to beworn by operating room personnelduring surgical procedure to protectboth the surgical patient and theoperating room personnel fromtransfer of microorganisms, bodyfluids, and particulate material.Per ANSI/AAMI PB70:2012 Liquidbarrier performance andclassification of protective appareland drapes intended for use inhealth care facilities, SMS StandardSurgical Gown and SMS SurgicalGown with Reinforcement met therequirements for Level 3classification; BVB Surgical Gownand BVB Splicing Surgical Gownmet the requirements for Level 4classification.	Same
Style	Non-reinforced	Non-reinforced	Same
Use	Single use, disposable	Single use, disposable	Same

Table 4. General Comparison for BVB Surgical Gown

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Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same

Table 5. Safety and Effectiveness Comparison for BVB Surgical Gown

Item	Proposed DeviceK221819	Predicate Device 2K192290	Remark
Product Name	BVB Surgical Gown	BVB Surgical Gown	/
Weight persquare (g)	64g/m²	68g/m²	Different
Size	M, L, LL, XL, XLL, XXL	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	BVB Surgical Gown (Non-sterile):Latitude: 148.44NLongitude: 236.60N	Latitude: 92.3NLongitude: 177.11N	Different
	BVB Surgical Gown (Sterile):Latitude:148.93NLongitude: 237.72 N
Tearingstrength	BVB Surgical Gown (Non-sterile):Latitude: 49.76NLongitude: 53.97N	Latitude: 35.30Nlongitude: 56.46N	Different
	BVB Surgical Gown (Sterile):Latitude: 49.23NLongitude: 53.98 N
Seam strength	BVB Surgical Gown (Non-sterile):70.27NBVB Surgical Gown (Sterile): 70.35N	>70N	Different
Linting	Log10(particle count) <4	Log10(particle count) <4	Same
Viral barrier(resistance tobacteriophagePhi-X174)	Pass	Pass	Same
Barrierprotectionlevel	Level 4 per AAMI PB 70	Level 4 per AAMI PB 70	Same
Material	Standard SMMS Surgical Gown:Non woven SMMS Fabric, Polyester	SMS nonwoven, white knitted cuff,white spunbond and BVB	Different

	Mixing polyester with nylonReinforced SMMS Surgical Gown:Non-woven SMMS Fabric, Polyester,Mixing polyester with nylon, PP andPE fabric
Biocompatibility
Cytotoxicity	Under the conditions of the study, the	Under the conditions of the study, thedevice is non-toxic,	Same
IrritationSensitization	device is non-toxic, non-irritating, andnon-sensitizing.	non-irritating, and non-sensitizing.
Sterilization	Sterile/Non-sterile	Sterile
	Sterile Method: Ethylene Oxide (EO);	Method: Ethylene Oxide (EO);
	Sterilization Assurance Level (SAL):	Sterilization Assurance Level(SAL):	Different
	10-6	10-6
EthyleneOxide	EO:<4mg/deviceECH:<9mg/device	EO:<4mg/deviceECH:<9mg/device	Same

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Different - Weight per square

The weight per square for the proposed device is different from the predicate device K192290. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed devices 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 device is different from the predicate device K192290. The proposed devices are available in 6 product sizes, including M, L, LL, XL, XL, XL, 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 device is different from the predicate device K192290. The breaking strength refers to the ability of the surgical gown to withstand destructive force. The greater the breaking strength value, the stronger the ability to withstand destructive force. The latitude and longitude breaking strength for the proposed device is larger than the predicate device. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Tearing strength

The tearing strength for the proposed device is similar to the predicate device K192290. And the tearing strength testing results demonstrate that the tearing strength of the proposed device meets ASTM

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F2407-20's requirement of greater than 10N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Seam strength

The seam strength for the proposed device is different from the predicate device K192290. However, the seam strength was conducted on the proposed device and the testing results demonstrate that the seam strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Material

The material for the proposed device is different from the predicate device K192290. 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.

Different - Sterilization

The proposed devices are available in two sterilization states, sterile and non-sterile, while the predicate device K192290 is only available in sterilized state. However, the non-sterilized surgical gown is required to be used after sterilization, and the recommended sterilization parameters for non-sterilized surgical gowns are the same as sterilized surgical gowns. The performance test report after sterilization shows that the proposed device is acceptable. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

7. 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 devices. The test results demonstrated that the proposed device complies with the following standards:

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
A AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
A 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;
A 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;

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ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials; >
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;
ISO 10993-1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
▲ ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

TestMethodology	Purpose	Acceptance Criteria	Result
Flammability	The test was performed inaccordance with 16 CFRPart 1610 Standard for theFlammability of ClothingTextiles to evaluate theflammability of the testsample.	Meets Class 1requirements	Class 1
Hydrostaticpressure	The test was performed inaccordance with AATCC127: 2018 WaterResistance: HydrostaticPressure Test to determinethe hydrostatic pressure ofthe test sample.	Level 2 SurgicalGown: >20 cm H2O;Level 3 SurgicalGown: >50 cm H2O;Level 4 SurgicalGown: >50 cm H2O;	35g Standard SMMS SurgicalGown (Non-sterile): Average40.57cm;35g Standard SMMS SurgicalGown (Sterile): Average40.21cm;35g Reinforced SMMS SurgicalGown (Non-sterile): Average83.53cm;
			35g Reinforced SMMS SurgicalGown (Sterile): Average83.57cm;43g Standard SMMS SurgicalGown (Non-sterile): Average60.50 cm;43g Standard SMMS SurgicalGown (Sterile): Average 60.48cm;43g Reinforced SMMS SurgicalGown (Non-sterile): Average99.59 cm;43g Reinforced SMMS SurgicalGown (Sterile): Average 98.90cm;50g Standard SMMS SurgicalGown (Non-sterile): Average83.19 cm;50g Standard SMMS SurgicalGown (Sterile): Average 83.02cm;50g Reinforced SMMS SurgicalGown (Non-sterile): Average108.37 cm;50g Reinforced SMMS SurgicalGown (Sterile): Average 108.37cm;BVB Surgical Gown(Non-sterile): Average 161.71cm;BVB Surgical Gown (Sterile):Average162.11 cm
Water impact	The test was performed inaccordance with AATCC127: 2017 WaterResistance: HydrostaticPressure Test to determinethe hydrostatic pressure ofthe test sample.	≤1.0 g;	35g Standard SMMS SurgicalGown (Non-sterile): Average0.041g;35g Standard SMMS SurgicalGown (Sterile): Average 0.03g;35g Reinforced SMMS SurgicalGown (Non-sterile): Average
			0.03g;
			35g Reinforced SMMS SurgicalGown (Sterile): Average 0.029g;
			43g Standard SMMS SurgicalGown (Non-sterile): Average0.036g;
			43g Standard SMMS SurgicalGown (Sterile): Average 0.033g;
			43g Reinforced SMMS SurgicalGown (Non-sterile): Average0.032g;
			43g Reinforced SMMS SurgicalGown (Sterile): Average 0.032g;
			50g Standard SMMS SurgicalGown (Non-sterile): Average0.031g;
			50g Standard SMMS SurgicalGown (Sterile): Average 0.034g;
			50g Reinforced SMMS SurgicalGown (Non-sterile): Average0.033g
			50g Reinforced SMMS SurgicalGown (Sterile): Average 0.031g;
			BVB Surgical Gown(Non-sterile): Average 0.078g;
			BVB Surgical Gown (Sterile):Average0.079g
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	35g Standard SMMS SurgicalGown (Non-sterile):Latitude: 108.37N;Longitude: 161.87N;
			35g Standard SMMS SurgicalGown (Sterile):Latitude: 108.37NLongitude: 161.87N;
			35g Reinforced SMMS SurgicalGown (Non-sterile):Latitude: 108.72NLongitude: 161.19N;

Table 6. Summary of Performance Testing

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	35g Reinforced SMMS SurgicalGown (Sterile):Latitude: 108.53NLongitude: 161.31N;
	43g Standard SMMS SurgicalGown (Non-sterile):Latitude: 113.34NLongitude: 182.30N;
	43g Standard SMMS SurgicalGown (Sterile):Latitude: 113.01NLongitude: 181.05 N;
	43g Reinforced SMMS SurgicalGown (Non-sterile):Latitude: 113.72NLongitude: 181.14 N;
	43g Reinforced SMMS SurgicalGown (Sterile):Latitude: 112.60NLongitude: 181.26N;
	50g Standard SMMS SurgicalGown (Non-sterile):Latitude: 137.58NLongitude: 190.87 N;
	50g Standard SMMS SurgicalGown (Sterile):Latitude: 137.77NLongitude: 188.30 N;
	50g Reinforced SMMS SurgicalGown (Non-sterile):Latitude: 138.02NLongitude: 191.32N;
	50g Reinforced SMMS SurgicalGown (Sterile):Latitude: 138.39NLongitude: 190.07 N;
	BVB Surgical Gown(Non-sterile):Latitude: 148.44NLongitude: 236.60N

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Tearingstrength	The test was performed inaccordance with ASTMD5587:2015(2019)Standard Test Method forTearing Strength of Fabricsby Trapezoid Procedure toevaluatethetearingstrength of the test sample.	≥10N	BVB Surgical Gown (Sterile):Latitude:148.93NLongitude: 237.72 N35g Standard SMMS SurgicalGown (Non-sterile):Latitude: 32.49 NLongitude: 39.67 N;35g Standard SMMS SurgicalGown (Sterile):Latitude: 32.31NLongitude: 39.81N;35g Reinforced SMMS SurgicalGown (Non-sterile):Latitude: 32.44NLongitude: 39.67N;35g Reinforced SMMS SurgicalGown (Sterile):Latitude: 32.55NLongitude: 39.92N;43g Standard SMMS SurgicalGown (Non-sterile):Latitude: 33.99NLongitude: 41.40N;43g Standard SMMS SurgicalGown (Sterile):Latitude: 33.92NLongitude: 41.75N;43g Reinforced SMMS SurgicalGown (Non-sterile)Latitude: 34.09NLongitude: 41.51;43g Reinforced SMMS SurgicalGown (Sterile):Latitude: 34.01NLongitude: 41.18N;50gStandard SMMS Surgical Gown(Non-sterile):Latitude: 44.02NLongitude: 54.18N;50gStandard SMMSSurgical

			Gown (Sterile):Latitude: 44.36NLongitude: 54.07N;50g Reinforced SMMS SurgicalGown (Non-sterile):Latitude: 43.93NLongitude: 53.96N;50g Reinforced SMMS SurgicalGown (Sterile):Latitude: 44.30NLongitude: 54.25N;BVB Surgical Gown(Non-sterile):Latitude: 49.76NLongitude: 53.97NBVB Surgical Gown (Sterile):Latitude: 49.23NLongitude: 53.98 N
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(particle count)< 4	35g Standard SMMS SurgicalGown (Non-sterile): Average2.89;
			35g Standard SMMS SurgicalGown (Sterile): Average 2.89;
			35g Reinforced SMMS SurgicalGown (Non-sterile): Average2.89;
			35g Reinforced SMMS SurgicalGown (Sterile): Average 2.90;
			43g Standard SMMS SurgicalGown (Non-sterile): Average2.50;
			43g Standard SMMS SurgicalGown (Sterile): Average 2.47;
			43g Reinforced SMMS SurgicalGown (Non-sterile): Average2.47;
			43g Reinforced SMMS SurgicalGown (Sterile): Average 2.54;
			50g Standard SMMS SurgicalGown (Non-sterile): Average
			2.50;
			50g Standard SMMS SurgicalGown (Sterile): Average 2.51;
			50g Reinforced SMMS SurgicalGown (Non-sterile): Average2.47;
			50g Reinforced SMMS SurgicalGown (Sterile): Average 2.48;
			BVB Surgical Gown(Non-sterile): Average 2.54;
			BVB Surgical Gown (Sterile):2.52
	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	35g Standard SMMS SurgicalGown (Non-sterile): Average41.90N
			35g Standard SMMS SurgicalGown (Sterile): Average 42.21N
			35g Reinforced SMMS SurgicalGown (Non-sterile): Average41.75N
			35g Reinforced SMMS SurgicalGown (Sterile): Average 41.74N
			43g Standard SMMS SurgicalGown (Non-sterile): Average44.51N
			43g Standard SMMS SurgicalGown (Sterile): Average 44.56N
			43g Reinforced SMMS SurgicalGown (Non-sterile): Average44.55N
			43g Reinforced SMMS SurgicalGown (Sterile): Average 44.34N
			50g Standard SMMS SurgicalGown (Non-sterile): Average50.52N
			50g Standard SMMS SurgicalGown (Sterile): Average 50.45N
			50g Reinforced SMMS SurgicalGown (Non-sterile): Average50.45N
Seamstrength
			50g Reinforced SMMS Surgical Gown (Sterile): Average 50.57N
			BVB Surgical Gown (Non-sterile): 70.27N
			BVB Surgical Gown (Sterile): 70.35N
	The test was performed in accordance with ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics to evaluate the air permeability of the test sample.		35g Standard SMMS Surgical Gown (Non-sterile): Average 70.65 ft³/min/ft²
			35g Standard SMMS Surgical Gown (Sterile): Average 68.89 ft³/min/ft²
			35g Reinforced SMMS Surgical Gown (Non-sterile): Average 70.67 ft³/min/ft²
			35g Reinforced SMMS Surgical Gown (Sterile): Average 69.94 ft³/min/ft²
Air permeability		≥30 ft³/min/ft²	43g Standard SMMS Surgical Gown (Non-sterile): Average 65.05 ft³/min/ft²
			43g Standard SMMS Surgical Gown (Sterile): Average 65.51 ft³/min/ft²
			43g Reinforced SMMS Surgical Gown (Non-sterile): Average 65.76 ft³/min/ft²
			43g Reinforced SMMS Surgical Gown (Sterile): Average 66.56 ft³/min/ft²
			50g Standard SMMS Surgical Gown (Non-sterile): Average 62.03 ft³/min/ft²
			50g Standard SMMS Surgical Gown (Sterile): Average 62.15 ft³/min/ft²
			50g Reinforced SMMS Surgical Gown (Non-sterile): Average 62.12 ft³/min/ft²
			50g Reinforced SMMS Surgical

			Gown (Sterile): Average 62.06 ft³/min/ft²
Viral barrier(resistance tobacteriophagePhi-X174)	The test was performed inaccordance with ASTMF1671/F1671M-13Standard Test Method forResistance of MaterialsUsed in ProtectiveClothing to Penetration byBlood-Borne PathogensUsing Phi-X174Bacteriophage Penetrationas a Test System evaluatethe resistance tobacteriophage penetration	No bacteriophagepenetration	For BVB Surgical Gowns only.No bacteriophage penetration
EthyleneOxideResiduals	The test was performed inaccordance with ISO10993-7:2008 Biologicalevaluation of medicaldevices - Part 7: Ethyleneoxide sterilizationresiduals to evaluate thelevel of sterilant residues.	EO:<4mg/deviceECH:<9mg/device	EO Residue: 0.84 mg/device;ECH Residue: 1.18 mg/device

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Table 7. Summary of Biocompatibility Testing

TestMethodology	Purpose	Acceptance Criteria	Result
Cytotoxicity	The test was performed in accordance with ISO 10993-5 Third edition2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity to evaluate the cytotoxicity of the test sample.	The viability should be $\ge$ 70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract.	The viability was $\ge$ 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	The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological	Non-sensitizing	Under the conditions of the study, the proposed device was non-sensitizing.

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	evaluation of medicaldevices - Part 10: Tests forirritation and skinsensitization to evaluatethe sensitization of the testsample.
Irritation	The test was performed inaccordance with ISO10993-10 Third Edition2010-08-01 Biologicalevaluation of medicaldevices - Part 10: Tests forirritation and skinsensitization to evaluatethe irritation of the testsample.	Non-irritating	Under the conditions of the study,the proposed device wasnon-irritating.

8. Clinical Test Conclusion

No clinical study is included in this submission.

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 device K211422 for the level 2 and level 3 gowns and K192290 for the level 4 gowns.

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.