High protection 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, the high protection surgical gown met the requirements for Level 4 classification.

Device Description

The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.

AI/ML Overview

The medical device in question is a High Protection Surgical Gown (product code FYA, regulation number 21 CFR 878.4040, Class II).

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Flammability (16 CFR Part 1610)	Evaluate flammability of the test sample.	Meets requirements	Class 1
Hydrostatic Pressure (AATCC 127)	Determine hydrostatic pressure of the test sample.	≥50 cm H2O	204.6 cm H2O
Water Impact (AATCC 127)	Determine hydrostatic pressure of the test sample (likely a typo, AATCC 42 is typically for impact penetration).	≤1.0 g	0.02g
Breaking Strength (ASTM D 5034)	Evaluate breaking strength of the test sample.	≥30 N	Longitude: 131.5N, Latitude: 75.2N
Tearing Strength (ASTM D5587)	Evaluate tearing strength of the test sample.	≥10 N	Longitude: 79.0N, Latitude: 33.8N
Linting (ISO 9073-10)	Evaluate linting of the test sample.	Log10(particle count) < 4	Side A: 3.1, Side B: 3.2
Seam Strength (ASTM D1683/D1683M)	Evaluate seam strength of the test sample.	≥30 N	Shoulder Seam: 126.5N, Sleeve Seam: 76.7N, Armhole Seam: 75.3N
Resistance against penetration of Phi-X174 bacteriophage (ASTM F 2407-2020)	Evaluate resistance to penetration by blood-borne pathogens.	No detectable transfer of the Phi-X174 Bacteriophage	No detectable transfer of the Phi-X174 Bacteriophage
EO/ECH Residue (ISO 10993-7)	Evaluate the level of sterilant residues.	EO: <4mg/device, ECH: <9mg/device	The Method Detection Limit (MDL) of EO residue and ECH residue is 0.093mg/device. The total EO residue and ECH residue of the devices were less than the MDL.
Cytotoxicity (ISO 10993-5)	Evaluate cytotoxicity of the test sample.	Viability ≥ 70% of the blank, 50% extract viability ≥ 100% extract viability.	The viability was ≥ 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic.
Sensitization (ISO 10993-10)	Evaluate sensitization of the test sample.	Non-sensitizing	Under the conditions of the study, the proposed device was non-sensitizing.
Irritation (ISO 10993-10)	Evaluate irritation of the test sample.	Non-irritating	Under the conditions of the study, the proposed device was non-irritating.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gowns tested for flammability or breaking strength). However, the tests are described as being performed "in accordance with" specific international and national standards (e.g., AATCC, ASTM, ISO, CFR). These standards typically prescribe minimum sample sizes for reliable testing.

Data Provenance: The document indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device." Given that the manufacturer is 3A Medical Products Co., Ltd in China, the tests were presumably conducted in China or by labs contracted by the manufacturer. The data is retrospective as it was collected as part of the device development and verification process.

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

This information is not applicable to this type of device and study. This is a performance and biocompatibility study for a physical medical device (surgical gown), not an AI/software device that requires expert review for ground truth establishment. The "ground truth" for these tests is defined by the objective measurement criteria within the specified standards.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the "ground truth" is based on objective, standardized test methodologies and their defined acceptance criteria, not on human interpretation that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This document describes the performance testing of a physical medical device (surgical gown) and does not involve AI or human readers for diagnostic interpretation.

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

This is not applicable. This document describes the performance testing of a physical medical device (surgical gown) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for this study is based on objective, standardized measurement criteria and physical material properties as defined by the referenced national and international standards (e.g., 16 CFR Part 1610 for flammability, AATCC 127 for hydrostatic pressure, ASTM D 5034 for breaking strength, ISO 10993-10 for irritation). These standards provide quantifiable metrics and methodologies against which the device's performance is measured.

8. The Sample Size for the Training Set

This is not applicable. This document describes the performance testing of a physical manufactured product (surgical gown), not a machine learning model. Therefore, there is no "training set."

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

This is not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply here.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

March 12, 2023

3A Medical Products Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K222456

Trade/Device Name: High Protection Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 6, 2023 Received: February 8, 2023

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.

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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 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

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K222456

Device Name High Protection 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, the high protection surgical gown met the requirements for Level 4 classification.

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 K222456

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

The assigned 510(k) Number: K222456

1. Date of Preparation: 02/07/2023
1. Sponsor Identification

ЗА MEDICAL PRODUCTS СО., LTD

Yuan Industrial Park, Liuan City, China 237100 Establishment Registration Number: 3013735189

Contact Person: Amy Ma Position: Sales Director Tel: 86-551-64456982 Fax: 86-551-6556979 Email: info@3a-medical.cn

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: High Protection 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:

1. Identification of Predicate Device
  510(k) Number: K212869

Product Name: Disposable Surgical Gown ML515M45U Disposable Surgical Gown GD524ME65 (Selected as the predicate device) Disposable Reinforced Surgical Gown

1. Identification of Reference Device

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510(k) Number: K221819 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; BVB Surgical Gown (Sterile status was selected as the reference device)

Summary of Non-Clinical Test 7.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
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;
ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
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 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;

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TestMethodology	Purpose	AcceptanceCriteria	Result
Flammability	The test was performed in accordancewith 16 CFR Part 1610 Standard forthe Flammability of Clothing Textilesto evaluate the flammability of thetest sample.	Meetsrequirements	Class 1
Hydrostaticpressure	The test was performed in accordancewith AATCC 127: 2017 WaterResistance: Hydrostatic Pressure Testto determine the hydrostatic pressureof the test sample.	≥50 cm H2O	204.6 cm H2O
Water impact	The test was performed in accordancewith AATCC 127: 2017 WaterResistance: Hydrostatic Pressure Testto determine the hydrostatic pressureof the test sample.	≤1.0 g	0.02g
Breakingstrength	The test was performed in accordancewith ASTM D 5034:2009(2017)Standard Test Method for BreakingStrength and Elongation of TextileFabrics (Grab Test) to evaluate thebreaking strength of the test sample.	≥30 N	Longitude:131.5NLatitude:75.2N
Tearingstrength	The test was performed in accordancewith ASTM D5587:2015(2019)Standard Test Method for TearingStrength of Fabrics by TrapezoidProcedure to evaluate the tearingstrength of the test sample.	≥10 N	Longitude:79.0N;Latitude:33.8N
Linting	The test was performed in accordancewith ISO 9073-10:2003 Textiles-TestMethods for Nonwovens-Pat 10: Lintand Other Particles Generation in theDry State to evaluate the linting ofthe test sample.	Log10(particlecount) < 4	Side A:3.1Side B:3.2
Seam strength	The test was performed in accordancewith ASTM D1683/D1683M:2017(2018) Standard Test Method forFailure in Sewn Seams of Woven	≥30 N	Shoulder Seam:126.5NSleeve Seam:76.7NArmhole Seam:75.3N
	Fabrics to evaluate the seam strengthof the test sample.
ResistanceagainstpenetrationofPhi-X174bacteriophage	The test was performed in accordancewith ASTM F 2407-2020 StandardSpecification for Surgical GownsIntended for Use in HealthcareFacilities	No detectabletransfer of thePhi-X174Bacteriophage	No detectable transferof the Phi-X174Bacteriophage
EO/ECHResidue	The test was performed in accordancewith ISO 10993-7:2008 Biologicalevaluation of medical devices - Part7: Ethylene oxide sterilizationresiduals to evaluate the level ofsterilant residues.	EO:<4mg/deviceECH:<9mg/device	The Method DetectionLimit (MDL) of EOresidue and ECHresidue is0.093mg/device. Thetotal EO residue andECH residue of thedevices were less thanthe MDL.

Table 1 Summary of Performance Testing

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Summary of Biocompatibility Testing Table 2

TestMethodology	Purpose	AcceptanceCriteria	Result
Cytotoxicity	The test was performed in accordancewith ISO 10993-5 Third edition2009-06-01 Biological evaluation ofmedical devices - Part 5: Tests for invitro cytotoxicity to evaluate thecytotoxicity of the test sample.	Theviabilityshould be $\ge$ 70%of the blank. Andthe 50% extract ofthe test sampleshould have atleast the same or ahigherviabilitythan the 100%extract.	The viability was $\ge$ 70%of the blank. And the50% extract of the testsample had a higherviability than the 100%extract. Under theconditions of the study,the proposed devicewas non-cytotoxic.
Sensitization	The test was performed in accordancewith ISO 10993-10 Third Edition2010-08-01 Biological evaluation ofmedical devices - Part 10: Tests forirritation and skin sensitization toevaluate the sensitization of the testsample.	Non-sensitizing	Under the conditions ofthe study, the proposeddevicewasnon-sensitizing.
Irritation	The test was performed in accordancewith ISO 10993-10 Third Edition2010-08-01 Biological evaluation of	Non-irritating	Under the conditions ofthe study, the proposeddevicewas

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medical devices - Part 10: Tests forirritation and skin sensitization toevaluate the irritation of the testsample.		non-irritating.
--------------------------------------------------------------------------------------------------------------------------------	--	-----------------

Summary of Clinical Test 8.

No clinical study is included in this submission.

Summary of Technological characteristics 9.

Item	Proposed Device	PredicateDeviceK212869	ReferenceDeviceK221819	Remark
ProductName	High protection surgicalgown	Disposable SurgicalGown GD524ME65	BVB Surgical Gown(Sterile)	/
ProductCode	FYA	FYA	FYA	Same
RegulationNo.	21CFR 878.4040	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	II	Same
Indicationfor Use	High protection 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, the high	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	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	Different

	protection surgical gownmet the requirements forLevel 4 classification.	drapes intended for usein health care facilities,Disposable SurgicalGown ML515M45U metthe requirements forLevel 3 classification,Disposable SurgicalGown GD524ME65 andDisposable ReinforcedSurgical Gown met therequirements of Level 4classification.	Standard SMMS SurgicalGown met therequirements for Level 2classification; 35gSMMS ReinforcedSurgical Gown, 43gStandard SMMS SurgicalGown, 43g ReinforcedSMMS Surgical Gown,50g Standard SMMSSurgical Gown and 50gReinforced SMMSSurgical Gown met therequirements for Level 3classification;BVBSurgical gown met therequirements for Level 4classification. Non-sterilegowns are to be sold tore-packager/re-labelerestablishments forethylene oxide (EtO)sterilization according toISO 11135-1 prior tomarketing to the endusers and sterile surgicalgowns are to be solddirectly to the end usersafter EtO sterilizationvalidation to ISO11135-1.
Style	Non-reinforced	Non-reinforced	Non-reinforced	Same
Durability	Single use, Disposable	Single use, Disposable	Single use, Disposable	Same
Color	Blue	Blue	Blue	Same
Labeling	Conform with 21CFR Part801	Conform with 21CFRPart 801	Conform with 21CFRPart 801	Same
Item	Proposed Device	Table 4 Safety and Effectiveness ComparisonPredicate Device K212869		Device Reference K221819	Remark
Product Name	High protection surgical gown	Disposable Surgical Gown GD524ME65		BVB Surgical Gown (Sterile)	/
Weight per square (g)	80 g/m²	67g/m²		64 g/m²	Different
Size	S, M, L, XL, XXL	S, M, L, XL, XXL, XXXL		M, L, LL, XL, XLL, XXL	Different
Flammability	Class I	Class I		Class I	Same
Hydrostatic pressure	≥50 cm H2O	>50 cm H2O		>50 cm H2O	Same
Water impact	≤1.0 g	≤1.0 g		≤1.0 g	Same
Breaking strength	Longitude:131.5NLatitude:75.2N	Longitude: 184 NLatitude: 111 N		Longitude: 237.72 NLatitude: 148.93N	Different
Tearing strength	Longitude:79.0N;Latitude:33.8N	Longitude: 137 NLatitude: 90 N		Longitude: 53.98 NLatitude: 49.23N	Different
Linting	Log10<4	Log10<4		Log10<4	Same
Seam Strength	Shoulder Seam: 126.5NSleeve Seam: 76.7NArmhole Seam: 75.3N	117N		70.35N	Different
Bacterial Penetration	No detectable transfer of the Phi-X174 Bacteriophage	No detectable transfer of the Phi-X174 Bacteriophage		No detectable transfer of the Phi-X174 Bacteriophage	Same
Barrier protection level	Level 4 per AAMI PB 70	Level 4 per AAMI PB 70		Level 4 per AAMI PB 70	Same
Material	Blue SFS 3-Ply Lamination Material, Blue PP Spunbond Nonwoven Fabric, Polyester Fiber and Nylon	SMS nonwoven, PE film, Polyester and blue masterbatch;		Blue BVB fabric, PP non-woven, Polyester and Mixing polyester with nylon	Different
	Biocompatibility
Cytotoxicity	Under the conditions of the study, the device is	Under the conditions of the study, the device is		Under the conditions of the study, the device is	Same
IrritationSensitization	non-toxic, non-irritating,and non-sensitizing.	non-toxic, non-irritating,and non-sensitizing.	non-toxic, non-irritating,and non-sensitizing.
Sterilization	SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level (SAL): 10-6	SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level (SAL): 10-6	SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level (SAL): 10-6	Same

Table 3 General Comparison

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Different - Indication for Use

The predicate device and reference device are available in many types. The type GD524ME65 in K212869 is selected as the predicate device, and the BVB Surgical Gown (Sterile) in K221819 is

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selected as the reference device. The indications for use for the proposed device, predicate device and reference device are the same.

Table 4 Safety and Effectiveness Comparison

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Different - Weight per square

The weight per square for the proposed device is different from the predicate device and reference 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 device 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 and reference device. The proposed devices are available in 5 product sizes, including S, M, L, XL 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 - Breaking strength

The breaking strength for the proposed device is different from the predicate device and reference device. Although the longitude and latitude breaking strength of the proposed device are smaller than the predicate device and reference device, the longitude and latitude 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 and reference device. However, the longitude and latitude 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 and reference device. The shoulder seam strength, sleeve seam strength and armhole seam strength were conducted on the proposed device. The sleeve seam strength and armhole seam strength of the proposed device are smaller than the predicate device, while these seam strengths are similar to the reference device. And

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these 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 and reference 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.

10. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and perform as well as or better than the legally marketed predicate device K212869.

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.