The Disposable Ultra Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile

Device Description

The Disposable Ultra Reinforced Surgical Gown is reinforced surgical gown, which is comprised of a single layer blue non-woven fabric SMS, and an additional layer of SMS in critical zones of sleeve and front chest. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.

AI/ML Overview

The provided document describes the K173847 Disposable Ultra Reinforced Surgical Gown, for which a 510(k) premarket notification was submitted. The acceptance criteria and the study proving the device meets these criteria are outlined through a comparison to a predicate device and non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by being "same or better performance to the predicate device" (K170762 Cardinal Health Surgical Gown) and meeting specific industry standards.

Characteristic	Acceptance Criteria (Predicate Device K170762)	Reported Device Performance (Proposed Device)	Comparison
Intended Use	Protection for surgical patient and personnel from transfer of microorganisms, body fluids, and particulate material; AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012; single use, disposable; provided sterile.	Protection for surgical patient and personnel from transfer of microorganisms, body fluids, and particulate material; AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012; single use, disposable; provided sterile.	Same
Material	SMS polypropylene nonwoven	SMS polypropylene nonwoven	Same
Use	Single Use; Disposable	Single Use; Disposable	Same
Sterility	Sterile (and non-sterile)	Sterile	Same
Color	Blue	Blue	Same
Weight per square (g)	31g/m² (1.32 oz/yd²)	44 g/m²	Similar (Better)
Tensile	MD Mean 21.57 lbs; CD Mean 13.6 lbs	MD Mean ≥30 lbs; CD Mean≥25 lbs	Similar (Better)
Tear	MD Mean 3.47 lbs; CD Mean 5.63 lbs	MD Mean ≥9 lbs; CD Mean≥18 lbs	Similar (Better)
Flammability (sec.) CPSC, Part 1610	Class I	Class I	Same
Hydrostatic Pressure (cm) AATCC-127	>50 cm	>50 cm	Same
Water Impact (g) AATCC-42	≤1.0 g	≤1.0 g	Same
Resistance to blood and liquid penetration	Level 3 AAMI PB70	Level 3 AAMI PB70	Same
Biocompatibility (Cytotoxicity)	Not cytotoxic	Not cytotoxic	Same
Biocompatibility (Irritation)	No data for predicate (assumed acceptable previous clearance)	Not an irritant	Consistent
Biocompatibility (Sensitization)	No data for predicate (assumed acceptable previous clearance)	Not a sensitizer	Consistent
Sterilization Method & SAL	Ethylene Oxide (EO), SAL=10⁻⁶; EO/ECH residues meet ISO 10993-7	Ethylene Oxide (EO), SAL=10⁻⁶; EO/ECH residues meet ISO 10993-7	Same
Size	M-S, M, L, XL, XXL	S, M, L, XL	Similar (Covers key sizes)

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of gowns tested for tensile strength, hydrostatic pressure, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is from non-clinical tests conducted by the manufacturer, Xiantao Rayxin Medical Products Co., Ltd., and a third party, and is prospective as these tests were conducted on the proposed device to support its submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the evaluation of the surgical gown is based on objective, standardized physical and biological performance tests (e.g., tensile strength, fluid resistance, biocompatibility) rather than subjective expert interpretation or ground truth establishment typically associated with diagnostic or image-based devices. The "ground truth" for these tests is defined by the specific parameters and limits set by the referenced international and national standards (e.g., AAMI PB70:2012, ASTM, ISO).

4. Adjudication method for the test set

This information is not applicable. As stated above, the evaluation relies on objective measurements against defined standards, not on subjective assessments requiring adjudication among experts.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This submission is for a surgical gown, which is a physical medical device, not an AI or diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm or AI component.

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

The "ground truth" for the performance of the surgical gown is based on objective measurements against established national and international standards for material properties, barrier protection, and biocompatibility. These include:

AAMI/ANSI PB70:2012: Liquid Barrier Performance and Classification of Protective Apparel and Drapes
ISO 10993 Series: Biological Evaluation of Medical Devices (Part 5: Cytotoxicity, Part 10: Irritation and Skin Sensitization, Part 7: Ethylene oxide sterilization residuals)
ASTM F2407-06: Standard Specification For Surgical Gowns
CPSC 16 CFR Part 1610: Standard for the Flammability of clothing textiles
AATCC 127-2014: Water Resistance: Hydrostatic Pressure Test
AATCC 42-2013: Water Penetration Resistance: Impact Penetration Test
ASTM D5034-09: Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D5587-15: Tearing Strength of Fabrics by Trapezoid Procedure

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device and not an AI or machine learning model.

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

This information is not applicable as there is no training set for this device.

Summary

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

January 16, 2019

Xiantao Rayxin Medical Products Co., Ltd. Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing, 102401 Cn

Re: K173847

Trade/Device Name: Disposable Ultra Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 4, 2018 Received: December 7, 2018

Dear Ray 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Clarence W. Murray lii III -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173847

Device Name

Disposable Ultra Reinforced Surgical Gown

Indications for Use (Describe)

The Disposable Ultra Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSVAAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile

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 Title 21 CFR Section 807.92.

The assigned 510(k) Number: K173847

1. Date of Preparation:2019/01/16
1. Sponsor Identification

Xiantao Rayxin Medical Products Co., Itd. No. 258 Pengchang Road, Middle Street, Xiantao city, Hubei 433018, China

Contact Person: Liang Zhang Position: General Manager Tel: +86-728-2617592 Fax: +86-728-2617777 Email: zl@rayxin.com

Designated Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd

Email: Ray.Wang(@believe-med.com

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4. Identification of Predicate Device(s)

Predicate Device K170762 Cardinal Health Surgical Gown Cardinal Health 200, LLC

ર . Identification of Proposed Device

Trade Name: Disposable Ultra Reinforced Surgical Gown Common Name: Surgical Gown Model(s): S. M., L., XL

Regulatory Information Classification Name: Surgical Gown Classification: 2 Product Code: FYA Regulation Number: 878.4040 Review Panel: General & Plastic Surgery

Device Description

The subject devices are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate materials.

In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

The proposed devices are single use, disposable medical devices and provided sterile.

Indication for use Statement:

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Technological Characteristic Comparison Table 6.

Table 1 General Comparison

ITEM	Proposed Device	Predicate Device	Comparison
Intended Use	Disposable Ultra Reinforced Surgical Gown is intended to be worn by operatingroom personnel during surgical procedures to protect the surgical patient andoperating room personnel from the transfer of microorganisms, body fluids andparticulate material. In addition, this surgical gown meets the requirements ofAAMI Level 3 barrier protection for a surgical gown per ANSI/AAMIPB70:2012 Liquid barrier performance and classification of protective appareland drapes intended for use in health care facilities. It is single use, disposablemedical devices, provided sterile	Cardinal Health™ Non-Reinforced Surgical Gown is intended to be worn byoperating room personnel during surgical procedures to protect the surgical patientand operating room personnel from the transfer of microorganisms, body fluids andparticulate material. In addition, this surgical gown meets the requirements ofAAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012Liquid barrier performance and classification of protective apparel and drapesintended for use in health care facilities (AAMI PB70). The Cardinal Health™Non-Reinforced Surgical Gowns are single use, disposable medical devices;provided sterile and non-sterile.	SAME
	Material	SMS polypropylene nonwoven	SMS polypropylene nonwoven	SAME
	Use	Single Use; Disposable	Single Use; Disposable	SAME
	Sterility	Sterile	Sterile and non-sterile	SAME
	Color	Blue	Blue	SAME
	Weight per square (g)	$44 g/m^2$	$31g/ m^2 (1.32 oz/yd^2)$	Similar
	Tensile	MD Mean ≥30 lbs;CD Mean≥25 lbs	MD Mean 21.57 lbsCD Mean 13.6 lbs	Similar

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Tear	MD Mean ≥9 lbs;CD Mean≥18 lbs	MD Mean 3.47 lbsCD Mean 5.63 lbs	Similar
Flammability (sec.)CPSC, Part 1610	Class I	Class I	SAME
Hydrostatic Pressure(cm)AATCC-127	>50 cm	>50 cm	SAME
Water Impact (g)AATCC-42	≤1.0 g	≤1.0 g	SAME
Resistance to bloodand liquid penetration	Level 3 AAMI PB70	Level 3 AAMI PB70	SAME
Biocompatibility	Under the conditions of the study, the device extract was not cytotoxic.		SAME
	Under the conditions of the study, the non-polar and polar device extracts were not found to be an irritant.
	Under conditions of the study, the non-polar and polar device extracts were not found to be a sensitizer.
Sterilization Method& SAL	Ethylene Oxide (EO), SAL=10-6The EO/ECH residues meet the requirements of ISO 10993-7	Ethylene Oxide (EO), SAL=10-6The EO/ECH residues meet the requirements of ISO 10993-7	SAME
Size	S, M, L, XL	M-S, M, L, XL, XXL	SAME

Analysis: The proposed device has same or better performance to the predicate device. So we consider which is same with the predicate.

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1. Summary of Non-Clinical Performance Test
  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:
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 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ASTM F2407-06, Standard Specification For Surgical Gowns Intended For Use In Healthcare Facilities.
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles:
AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test;
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 Apparel > and Drapes Intended For Use In Health Care Facilities.
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Conclusion:
  The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K170762.

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.