Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided sterile.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 classification.

Device Description

The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.

The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.

The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed devices are disposable medical devices and provided in sterile.

AI/ML Overview

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Surgical Gown, Reinforced Surgical Gown (Wuhan Zonsen Medical Products Co.,Ltd)

1. Table of acceptance criteria and the reported device performance:

Item	Acceptance Criteria	Reported Device Performance (Surgical Gown / Reinforced Surgical Gown)
Flammability	Meets Class 1 requirements	Class 1 / Class 1 (PASS)
Hydrostatic pressure	Surgical Gown (Level 2): >20 cmReinforced Surgical Gown (Level 3): >50 cm	60 cm / 95 cm (PASS)
Water impact	≤1.0 g	0.1 g / 0 g (PASS)
Breaking strength	>20N	124N / 123N (PASS)
Tearing strength	>20N	52N / 61N (PASS)
Linting	$Log_{10}(particle\ count) < 4$	2.11 / 1.88 (PASS)
Cytotoxicity	Non-Cytotoxic	Under the conditions of the study, the device is non-cytotoxic. (PASS)
Irritation	Non-Irritating	Under the conditions of the study, the device is non-irritating. (PASS)
Sensitization	Non-Sensitizing	Under the conditions of the study, the device is non-sensitizing. (PASS)
Barrier protection level	Level 2 and 3 per AAMI PB 70 (This is an overarching requirement, specific tests are detailed above)	Met requirements for Level 2 (Surgical Gown) and Level 3 (Reinforced Surgical Gown) per ANSI/AAMI PB70:2012 (Implicitly PASS from individual tests)

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 specify the sample sizes used for each individual non-clinical test (e.g., how many surgical gowns were tested for flammability or hydrostatic pressure).
The data provenance is from China, as the applicant is "Wuhan Zonsen Medical Products Co.,Ltd" located in Wuhan, Hubei Province, China.
The studies were prospective as they were conducted to verify the device met design specifications for regulatory submission.

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 information is not applicable to this type of device (surgical gowns) and the non-clinical tests performed. These tests are standardized laboratory evaluations, not subjective expert assessments.

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

This information is not applicable. The tests are objective laboratory measurements against defined numerical or categorical criteria rather than requiring adjudication of subjective expert opinions.

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:

No MRMC comparative effectiveness study was done. This study is for a physical medical device (surgical gown), not an AI-powered diagnostic tool.

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

No standalone algorithm performance study was done. This device is a physical product, not an algorithm.

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

The ground truth for these tests is based on established industry standards and test methodologies (e.g., ISO 10993-5, AATCC 127, ASTM D5034, AAMI/ANSI PB70:2012). The "ground truth" is defined by the acceptance criteria set forth in these standards (e.g., hydrostatic pressure >20 cm, flammability Class 1).

8. The sample size for the training set:

Not applicable. This device is a physical product, not a machine learning model, therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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

December 15, 2021

Wuhan Zonsen Medical Products Co.,Ltd % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14 th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K212861

Trade/Device Name: Surgical Gown, Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 8, 2021 Received: September 8, 2021

Dear Ivy Wang:

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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212861

Device Name Surgical Gown, Reinforced Surgical Gown

Indications for Use (Describe)

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

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510(k) Summary

SECTION 5

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Wuhan Zonsen Medical Products Co.,Ltd No 8 Jinchao Road Zhucheng Street Xinzhou District Wuhan City Hubei Province, China,431400

510(K) Summary K212861

Document prepared date: 2021/12/13

A. Applicant:

Wuhan Zonsen Medical Products Co.,Ltd Address: No.8 Jinchao Road Zhucheng Street Xinzhou District Wuhan City Hubei Province, China, 431400 Contact Person: Cynthia Ye Tel : +86 02782737771

Submission Correspondent: ` Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Surgical Gown, Reinforced Surgical Gown Common Name: Surgical Gown Model(s): ZSG1005, ZSG1006

Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown Jiangsu Medplus Non-woven Manufacturer Co., Ltd.

D. Intended use of the device:

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E. Device Description:

The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.

The proposed devices are disposable medical devices and provided in sterile.

F. Comparison with predicate device

Device	Predicate Device	Proposed Device	Remark
Manufacturer	Jiangsu Medplus Non-wovenManufacturer Co., Ltd.	Wuhan Zonsen Medical ProductsCo.,Ltd	-
510K number	K211422	K212861	-
Model Name	Level 2 Standard Surgical Gown,Level 3 Standard Surgical Gown,Level 3 Reinforced Surgical Gown	Surgical Gown,Reinforced Surgical Gown,	-
Classification	Class II Device, FYA (21CFR878.4040)	Class II Device, FYA(21CFR878.4040)	Same
Intend use	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.	Surgical Gown is intended to beworn by room personnel duringsurgical procedures or otherinvasive tests to protect both thesurgical patient and operatingroom personnel from the transferof microorganisms, body fluidsand particulate material. This issingle use, disposable device,provided sterile.	Similar.No issuesof safety orefficacyraised.
Style	Non-reinforced/Reinforced	Non-reinforced/Reinforced	Same
Use	Single Use; Disposable; Sterile	Single Use; Disposable; Sterile	Same
Color	Blue	Blue	Same

Table 1 General Comparison

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Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
----------	-----------------------------	-----------------------------	------

Table 2 Safety and Performance Comparison

Item	Predicate Device	Proposed Device	Remark
Weight per square (g)	Level 2 Standard Surgical Gown: 35g/m2;Level 3 Standard Surgical Gown: 43g/m2Level 3 Reinforced Surgical Gown: 35g/m2 and 28g/m2	Surgical Gown: 45g/ m2;Reinforced Surgical Gown: 45g/m2	Difference resolved by performance testing
Size	XS, S, M, L, XL, XXL, XXXL	M, L, XL	Different. No affect on safety or efficacy
Flammability	Class I	Class I	Same
Hydrostatic pressure	Level 2 Standard Surgical Gown: >20 cm;Level 3 Standard Surgical Gown: >50 cm;Level 3 ReinforcedSurgical Gown: >50 cm	Surgical Gown: >20 cm;Reinforced Surgical Gown: >50 cm	Same
Water impact	≤1.0 g	≤1.0 g	Same
Breaking strength	>20N	>20N	Same
Tearing strength	>20N	>20N	Same
Linting	Log10(particle count) <4	Log10(particle count) <4	Same
Barrier protection level	Level 2 and 3 per AAMI PB 70	Level 2 and 3 per AAMI PB 70	Same
Material	Level 2 Standard Surgical Gown and Level 3 Standard Surgical Gown: SMS nonwoven, Polyester and Polyamide;Level 3 Reinforced Surgical Gown: SMS nonwoven,	Surgical Gown:SMMS non-woven, Cotton, and NylonReinforced Surgical Gown:SMMS non-woven, Cotton, Nylon, Polypropylene and	Similar

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	Polyester, Polyamide andHydrophilic nonwoven	Polyethylene
Sterility	Sterile	Sterile	Same
CytotoxicityIrritationSensitization	Under the conditions of thestudy, the device is non-toxic,non-irritating, and non-sensitizing.	Under the conditions of thestudy, the device is non-toxic,non-irritating, and non-sensitizing.	Same

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:

A 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
A CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
A AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test;
A AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test;
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective A Apparel and Drapes Intended For Use In Health Care Facilities.

Name of	Purpose	Acceptance Criteria	Results
Testing
Methodology
Flammability	The test was performed in accordancewith 16 CFR Part 1610 Standard for theFlammability of Clothing Textiles toevaluate the flammability of the testsample.	Meets Class 1requirements	PASSSurgical Gown:Class 1ReinforcedSurgical Gown:Class 1
	The test was performed in accordancewith AATCC 127: 2017 WaterResistance: Hydrostatic Pressure Test to	Surgical Gown(Level2): >20cm;	PASSSurgical Gown:

Table 3 Performance Testing

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	determine the hydrostatic pressure of		60cm
Hydrostaticpressure	the test sample.	ReinforcedSurgical Gown(Level 3): >50 cm	ReinforcedSurgical Gown:95cm
Water impact	The test was performed in accordancewith AATCC 42: 2017 WaterResistance: Impact Penetration Test toevaluate the water impact of the testsample.	≤1.0 g	PASSSurgical Gown:0.1gReinforcedSurgicalGown:0g
Breakingstrength	The test was performed In accordancewith ASTM D5034: 2009(2017)Standard.Test Method for Breaking Strength andElongation of Textile Fabrics (GrabTest) to evaluate the breaking strengthof the test sample.	>20N	PASSSurgical Gown:124NReinforcedSurgical Gown:123N
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.	>20N	PASSSurgical Gown:52NReinforcedSurgicalGown:61N
Linting	The test was performed in accordancewith ISO 9073-10: 2003 Textiles-TestMethods for Nonwovens-Part 10: Lintand Other Particles Generation in theDry State to evaluate the linting of thetest sample.	$Log_{10}(particle count) < 4$	PASSSurgical Gown:2.11ReinforcedSurgical Gown:1.88

Table 4 Biocompatibility Testing

Item	Purpose	Acceptance Criteria	Result
------	---------	---------------------	--------

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Cytotoxicity	The purpose of thebiocompatibility testing isto demonstrate thebiocompatibility of thesubject device.	Non-Cytotoxic	PASSUnder the conditions of thestudy, the device is non-cytotoxic.
Irritation		Non-Irritating	PASSUnder the conditions of thestudy, the device is non-irritating.
Sensitization		Non-Sensitizing	PASSUnder the conditions of thestudy, the device is non-sensitizing

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

Based on the comparison and analysis above, and the non-clinical tests performed, the proposed devices are determined to be as safe, as effective, and performs as well as the legally marketed predicate device under K211422.

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.