The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).The Surgical Isolation Gown is a single use, disposable medical nonsterile.

Device Description

The proposed SURGICAL Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material with the color in yellow. The SURGICAL Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.

AI/ML Overview

This document is a 510(k) premarket notification for a Surgical Isolation Gown. It aims to demonstrate substantial equivalence to a predicate device. Here's an extraction of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on meeting AAMI Level 3 barrier protection requirements as per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, and demonstrating biocompatibility.

Acceptance Criteria (Set by ANSI/AAMI PB70:2012 Level 3 & ISO 10993)	Reported Device Performance (K171535)
Liquid Barrier Performance (AAMI Level 3)
- Hydrostatic Head (AATCC 127)	CHEST/BACK/SLEEVE: Mean = 69 cm (Ind Min = 54, Ind Max = 84) - Meets Level 3 requirements, comparing favorably to predicate (Body/Sleeve: Mean = 69, Ind Min = 56, Ind Max = 84).
- Water Impact (AATCC-42)	Sleeve Seams: Mean = 0.04 g (Ind Min = 0.02, Ind Max = 0.08)CHEST: Mean = 0.04 g (Ind Min = 0.02, Ind Max = 0.05)Back: Mean = 0.05 g (Ind Min = 0.04, Ind Max = 0.07) - Meets Level 3 requirements, comparing favorably to predicate (Body/Sleeve: Mean = 0.08, Ind Min = 0.05, Ind Max = 0.13).
- Overall Liquid Barrier Classification	Device was tested in accordance with ANSI/AAMI PB70:2012 and meets Level 3 requirements for an isolation gown. The critical zone areas tested were the chest, the back, the sleeve seam, the belt seam, and side seam.
Physical Properties
- Grab tensile MD (ASTM D5034)	Mean = 20.71 lb (Ind Min = 19.73, Ind Max = 21.87) - Similar to predicate (Mean = 24.38, Ind Min = 21.94, Ind Max = 26.28).
- Grab tensile CD (ASTM D5034)	Mean = 12.21 lb (Ind Min = 11.20, Ind Max = 14.11) - Similar to predicate (Mean = 14.54, Ind Min = 12.70, Ind Max = 16.45).
- Trap Tear MD (ASTM D5587-15 Highest Peak)	Mean = 3.48 lbs (Ind Min = 2.82, Ind Max = 3.93) - Similar to predicate (Mean = 4.74, Ind Min = 3.67, Ind Max = 5.47).
- Trap Tear CD (ASTM D5587-15 Highest Peak)	Mean = 7.15 lbs (Ind Min = 6.20, Ind Max = 7.70) - Similar to predicate (Mean = 9.24, Ind Min = 7.54, Ind Max = 12.98).
- Flammability (CPSC, Part 1610)	Class I - Same as predicate.
Biocompatibility (ISO10993-5 and ISO10993-10)	Noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. - Same as predicate.
Lint and other particles generated in dry state	SIDE A: OUTSIDE: TOTAL >0.3 1024, TOTAL >0.5 658SIDE B: INSIDE: TOTAL >0.3 1066, TOTAL >0.5 697 - Performance values not available for predicate, but provided for the new device.

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

The document does not explicitly state the sample size for each performance test. However, for "Liquid Barrier Performance Classification Properties" for the proposed device, it mentions that "The critical zone areas tested were the chest, the back, the sleeve seam, the belt seam and side seam."

The data provenance is from non-clinical testing performed by Jingzhou Haixin Green Cross Medical Products Co., Ltd in China, as indicated by the applicant's address. The data is retrospective in the sense that these tests were conducted to support the 510(k) submission, not as a prospective clinical study involving human subjects.

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

This document describes a medical device (surgical gown) and its physical and barrier properties. It relies on standardized testing protocols (like ANSI/AAMI PB70:2012, AATCC, ASTM, ISO) rather than expert-derived ground truth from imaging or clinical data. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic algorithms is not applicable here. The "ground truth" is established by the specified test methods and their performance criteria.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective physical and chemical measurements based on industry standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a submission for a physical medical device (surgical gown), not an AI/software as a medical device.

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

Not applicable. This is a submission for a physical medical device (surgical gown), not an AI/software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is defined by the standardized test methods and their predetermined acceptance criteria (e.g., AAMI Level 3 specifications for barrier performance, Class I for flammability, non-cytotoxic/non-irritating/non-sensitizing for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

February 15, 2018

Jingzhou Haixin Green Cross Medical Products Co., Ltd % Raymond Luo Technical Manager Shanghai Sungo management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai, 200122 China

Re: K171535

Trade/Device Name: Surgical Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: January 9, 2018 Received: January 11, 2018

Dear Raymond Luo:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171535

Device Name SURGICAL ISOLATION 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

K 171535 Date of preparation: 2018-1-25

A. Applicant:

Name: Jingzhou Haixin Green Cross Medical Products Co., Ltd

Address: Room 916-918, Floor 9, International Finance Center, No.296, Xinhua Road, Wuhan City, Hubei Province, China

Official Contact Person Information

Name: Raymond Luo Tel: 0086-21-68828050 Mail: fda.sungo@gmail.com Shanghai Sungo Management Consulting Co., Ltd.

B. Device:

The proprietary name of the new device: SURGICAL ISOLATION GOWN Common Name: Isolation Gown Classification Name: Surgical Isolation Gown Classification regulation: 21 CFR 878.4040 Classification: Class II. Regulation Name: Surgical Apparel Product code: FYC

C. Predicate device:

K160339 Cardinal Health™ Isolation Gown Cardinal Health 200, LLC

D. Indications for use:

The Surgical Isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

E. Device Description

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Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.

Image /page/4/Figure/1 description: The image shows a diagram of a garment with various measurements labeled. The diagram includes labels such as A, B, C, D, E, F, G, H, and I, each pointing to a specific dimension of the garment. The garment appears to be a long-sleeved shirt or robe, and the measurements likely indicate the size and fit of the garment.

Size	Measurement Location (cm)
	A	B	C	D	E	F	G	H/I
Universal	119	138	22	62	31	7.5	13	24
XL	125	146	24	68	33	7.5	14.5	24.5
XXL	133	160	30	72	36	7.5	16	25

F. Comparison with predicate

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Device	K171535	K160339	Comparison
Manufacturer	Jingzhou Haixin Green Cross MedicalProducts Co., Ltd	Cardinal Health 200, LLC	NA
Model Name	SURGICAL ISOLATION GOWN	Cardinal Health™	NA
Classification	Class II Device, FYC (21CFR878.4040)	Class II Device, FYC (21CFR878.4040)	Same
Intend use	The Surgical Isolation Gown isintended to protect health care patientsand health care personnel from thetransfer of microorganisms, body fluidsand particulate material. Not intendedfor use in the operating room. Inaddition, the Surgical Isolation Gownmeets the requirements of an AAMILevel 3 barrier protection for anisolation gown per ANSI/AAMIPB70:2012 Liquid Barrier Performanceand Classification of Protective ApparelDrapes Intended for Use in Health CareFacilities (ANSI/AAMI PB70). TheSurgical Isolation Gown is a single use,disposable medical device providednon-sterile.	Cardinal Health Isolation Gown isintended to protect health care patientsand health care personnel from the transfer ofmicroorganisms, body fluids andparticulate material. Not intended foruse in the operating room. In addition,The Cardinal Health Isolation Gownmeets the requirements of an AAMILevel 3 barrier protection for anisolation gown per ANSI/AAMIPB70:2012 Liquid BarrierPerformance and Classification ofProtective Apparel and DrapesIntended for Use in Health CareFacilities (ANSI/AAMI PB70). TheCardinal Health IsolationGown is a single use, disposable medicaldevice provided non-sterile.	Similar

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Description	The Surgical Isolation Gown is asurgical isolation gown with moderatebarrier protection identified byRegulation 21 CFR 878.4040 underFDA product code, FYC. The SurgicalIsolation Gown is a single use,disposable medical device providednon-sterile. The Surgical IsolationGown is offered in yellow with threesizes. Each model is constructed of anon-woven material and has been testedaccording to ANSI/AAMI PB70:2012Liquid Barrier Performance andClassification of Protective Apparel andDrapes Intended for Use in Health CareFacilities and meets AAMI Level 3.	The Surgical Isolation Gown is asurgical isolation gown with moderatebarrier protection identified byRegulation 21 CFR 878.4040 underFDA product code, FYC. The SurgicalIsolation Gown is a single use,disposable medical device providednon-sterile. The Surgical IsolationGown is offered in two color (blue andyellow) models and each model isoffered in two sizes for a total of fourmodels. Each model is constructed of anon-woven material and has beentested according to ANSI/AAMIPB70:2012 Liquid BarrierPerformance and Classification ofProtective Apparel and DrapesIntended for Use in Health CareFacilities and meets AAMI Level 3.	Similar
Material	Polypropylene SMS non woven	Polypropylene SMS non woven	Same

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Composition
Design	Medical Tape Neck Closure	Medical Tape Neck Closure	Same
Features	White Belt TieSnap fastener	White Belt TieElastic Cuffs
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
Color	Yellow	Blue and Yellow	Similar

Element of Comparison	K171535	K160339	Comparison
Basis weight (oz/yd2)ASTM D3776	Testing not performed	Mean = 1.21Ind Min = 1.19Ind Max = 1.23	NA
Grab tensile MD (lb)ASTM D5034	Mean = 20.71Ind Min = 19.73Ind Max = 21.87	Mean = 24.38Ind Min = 21.94Ind Max = 26.28	Similar
Grab tensile CD (lb)ASTM D5034	Mean = 12.21Ind Min = 11.20Ind Max = 14.11	Mean = 14.54Ind Min = 12.70Ind Max = 16.45	Similar
Trap Tear MD, (lbs)ASTM D5587-15 Highest Peak	Mean = 3.48Ind Min = 2.82Ind Max = 3.93	Mean = 4.74Ind Min = 3.67Ind Max = 5.47	Similar
Trap Tear CD, (lbs)ASTM D5587-15 Highest Peak	Mean = 7.15Ind Min = 6.20Ind Max = 7.70	Mean = 9.24Ind Min = 7.54Ind Max = 12.98	Similar
Flammability CPSC, Part 1610	Class I	Class I	Same
Hydrostatic Head (cm)AATCC 127	CHEST/BACK/SLEEVE:Mean = 69Ind Min = 54Ind Max = 84	Body/Sleeve:Mean = 69Ind Min = 56Ind Max = 84	Similar
Water Impact (g)AATCC-42 (performed withwater per AATCC42:2013)	Sleeve Seams:Mean = 0.04Ind Min = 0.02Ind Max = 0.08CHEST:Mean = 0.04Ind Min = 0.02Ind Max = 0.05Back:Mean = 0.05Ind Min = 0.04Ind Max = 0.07	N/ABody/Sleeve:Mean = 0.08Ind Min = 0.05Ind Max = 0.13	Similar
Liquid Barrier Performance	Device was tested in	Device was tested in	Same
Classification Properties	accordance withANSI/AAMI PB70:2012and meets Level 3requirements for anisolation gown. The criticalzone areas tested were thechest, the back, the sleeveseam, the belt seam and sideseam.	accordance withANSI/AAMI PB70:2012and meets Level 3requirements for anisolation gown. The criticalzone areas tested were thebody and sleeve (samefabric), the sleeve seam,front belt or tie attachment,and the front seam armattachment using multiplelots.
Biocompatibility	The test was done againstISO10993-5 andISO10993-10. The resultindicates the gown isnoncytotoxic, non-irritating,and non-sensitizing per ISO10993-1.	Under the conditions ofeach study, the CardinalHealthTM Isolation gown isnoncytotoxic, non-irritating,and non-sensitizing per ISO10993-1.	Same
Sterilization Modality	None (Non-Sterile)	None (Non-Sterile)	Same
Lint and other particlesgenerated in dry state	SIDE A: OUTSIDETOTAL >0.3 1024TOTAL >0.5 658SIDE B: INSIDETOTAL >0.3 1066TOTAL >0.5 697	Performance values notavailable in predicate510(k) submission	NA

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G. Summary of Non-clinical tests

The SURGICAL Isolation gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition, and configuration/dimensions. Under the conditions of each study, the SURGICAL Isolation gown is non-cytotoxic, nonirritating, and non-sensitizing per ISO-10993 and have met the requirements of ANSVAAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 isolation gown.

H. Conclusion

The Surgical Isolation Gowns are as safe, as effective and performs as well as the legally marketed device identified in this submission.

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.