GRI's Non Reinforced, Film Reinforced, and Fabric Reinforced Surgical Gowns are sterile or non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Device Description

GRI's Non Reinforced, Film Reinforced and Fabric Reinforced Surgical Gowns are made from SMS fabrics and polypropylene/polyethylene protective reinforcement to provide user protection in surgical settings. The gowns are available in various designs and combinations of materials, sizes, and reinforcement configurations.

The Non Reinforced Surgical Gowns meet the requirements of AAMI Level 2 liquid barrier requirements.

The Fabric-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

The Film-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

AI/ML Overview

This document describes the validation of GRI Surgical Gowns for their liquid barrier properties and other physical characteristics, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document details that the GRI Surgical Gowns met acceptance criteria for various bench tests. While explicit numerical acceptance criteria are not provided, the performance is described in relation to AAMI liquid barrier levels and general physical properties.

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Liquid Barrier	Non Reinforced Surgical Gowns: AAMI Level 2 liquid barrier requirements.	GRI Non Reinforced Surgical Gowns: Met the requirements of AAMI Level 2 liquid barrier requirements.
	Fabric-Reinforced Surgical Gowns: AAMI Level 3 liquid barrier requirements.	GRI Fabric-Reinforced Surgical Gowns: Met the requirements of AAMI Level 3 liquid barrier requirements.
	Film-Reinforced Surgical Gowns: AAMI Level 3 liquid barrier requirements.	GRI Film-Reinforced Surgical Gowns: Met the requirements of AAMI Level 3 liquid barrier requirements.
Physical Properties	Biocompatibility, hydrostatic pressure, impact penetration, resistance to penetration by blood, "fly around" (likely referring to linting or air permeability/resistance), and strength via tensile, tear, and seam strength. (Specific numerical thresholds for these physical properties are not provided in the summary, but the document states they met acceptance criteria.)	GRI Surgical Gowns have met acceptance criteria for bench testing including biocompatibility, hydrostatic pressure, impact penetration, Resistance to Penetration by blood compatibility, fly around ity, and strength via tensile, tear and seam strength.

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. However, it indicates that "performance testing" was conducted. The data provenance is not specified, but the device manufacturer, GRI Medical & Electronic Technology Co., Ltd., is located in ZheJiang, China, suggesting the testing might have been conducted in China or by a certified testing facility accredited to international standards. The study is a retrospective submission for regulatory clearance (510(k)), meaning the testing was completed prior to the submission date.

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 to this testing. The "ground truth" for surgical gowns, in this context, is established by adherence to recognized national/international standards (like AAMI for liquid barrier properties) and standard test methods for physical properties. There is no involvement of human experts for "ground truth" establishment in the way it would be for a diagnostic AI device assessing medical images. The performance is objectively measured against physical/chemical standards.

4. Adjudication Method for the Test Set:

This information is not applicable. The testing involves objective physical measurements and comparisons against established technical standards (e.g., AAMI levels). There is no "adjudication" in the sense of resolving disagreements among human observers for image interpretation.

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 information is not applicable. The device under review is a surgical gown, a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant.

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

This information is not applicable. As a surgical gown, the device does not involve an algorithm or AI. Its performance is entirely standalone in terms of its physical properties and barrier function without human-in-the-loop interaction in a diagnostic or interpretive sense.

7. The Type of Ground Truth Used:

The "ground truth" for the device's acceptable performance is based on:

Established Standards: Adherence to AAMI (Association for the Advancement of Medical Instrumentation) liquid barrier classifications (Level 2 and Level 3).
Bench Testing Protocols: Standardized laboratory tests for physical properties such as biocompatibility, hydrostatic pressure, impact penetration, resistance to blood penetration, "fly around" (linting), tensile strength, tear strength, and seam strength. These tests have defined methodologies and criteria for pass/fail.

8. The Sample Size for the Training Set:

This information is not applicable. Since the device is a physical product and not an AI/machine learning model, there is no "training set."

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

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

Summary

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K102652

gri.
™

85. 510(k) Summary

FEB - 3 20i1

GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. 5.1 Submitted by: 1805 HongGao Road, XiuZhou Industry Zone, ZheJiang, China. 314031 86-573-83916501 86-573-83916520

Penny Northcutt 5.2 Contact Person: REGSolutions, LLC. 717 Lakeglen Drive Suwanee, GA 30024 Fax: (678) 513-0937 Phone: (678) 428-6978 Email: pennynorthcutt@theregsolutions.com

December 1, 2010 5.3 Summary Date:

Gowns Surgical 5.4 Device Name:
5.5 Common/Usual Name: Surgical gown

General & Plastic Surgery 5.6 Device Classification:

Class II - 21 CFR 878.4040

5.7 Device Product Code: FYA
5.8 Device Description:

The Non Reinforced Surgical Gowns meet the requirements of AAMI Level 2 liquid barrier requirements.

The Fabric-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

The Film-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

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Image /page/1/Picture/0 description: The image shows the logo for GRI, which stands for Global Reporting Initiative. The logo is in black and features the lowercase letters "gri" in a stylized font. A curved line extends from the top of the "i", adding a distinctive element to the design. The letters are bold and slightly slanted, giving the logo a dynamic appearance.

GRI Gowns	Predicate Gowns
Group 1 – Non Reinforced Surgical GownsProduct codes 90-10XX-S and 90-20XX-S	Kimberly Clark K093115KC 100 Surgical GownsProduct code 99284, 99285, 99294, 99295
GRI Gowns Group 2Film Reinforced Surgical GownsProduct codes 90-12XX-S and 90-22XX-S	Astound by Convertors K061308Impervious Film Reinforced SurgicalGowns, Product code Cat. 9040
GRI Gowns Group 3Fabric Reinforced Surgical GownsProduct codes 90-13XX-S and 90-24XX-S	Kimberly Clark K080795Fabric Reinforced Surgical GownsProduct code 95211

te Device Information and Substantial Equivalence:

GRI's Non Reinforced, Film Reinforced and Fabric Reinforced gowns are substantially equivalent to the above predicates in intended use statements, equivalent device construction, materials, gown design, and technology performance characteristics.

5.10 Indications for Use:

5.11 Summary of Testing:

GRI Surgical Gowns have met acceptance criteria for bench testing including biocompatibility, hydrostatic pressure, impact penetration, Resistance to Penetration by bloodmpatibility, fly around ity, and strength via tensile, tear and seam strength.

5.12 Conclusion:

Based on the performance testing and device attributes, it can be concluded that the GRI surgical gowns are equivalent to the predicate devices with respect to the indications for use and technological characteristics and do not present any further safety or effectiveness questions.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three overlapping human figures, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the graphic. The text is in a sans-serif font and is black in color.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

GRI Medical & Electronic Technology Company, Limited C/O Ms. Penny Northcutt Regsolutions, LLC 717 Lakeglen Drive Suwanee. Georgia 30024

Re: K102652

FEB - 3 201

Trade/Device Name: Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Il Product Code: FYA Dated: January 19, 2011 Received: January 20, 2011

Dear Ms. Northcutt:

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. - -

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Page 2- Ms. Northcutt

Enclosure

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 (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): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

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Indications for Use Form

Indications for Use: Sterile products

510(k) Number (if known): K102652

Device Name: Surgical Gowns

GRI's Non Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Non Reinforced Surgical Gowns meet Level 2 of the AAMI Liquid Barrier classifications. See Page 4-2 for product list.

GRI's Film Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Film Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-2 for product list.

GRI's Fabric Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Fabric Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-2 for product list.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use . X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 4-1 of 4-4

Eli, M.-м
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K102652

Page 63 of 236

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Indications for Use Product List: Sterile
Product Name	Model Code	Primary Material
GRI Non-Reinforced Surgicalgown	90-10XX-S	50gsm SMS in blue, Non-reinforced
GRI Non-Reinforced Surgicalgown	90-20XX-S	35gsm SMS in blue, Non-reinforced
GRI Film-Reinforced Surgicalgown	90-12XX-S	50gsm SMS in blue with film reinforcement
GRI Film-Reinforced Surgicalgown	90-22XX-S	35gsm SMS in blue with film reinforcement
GRI Fabric-Reinforced Surgicalgown	90-13XX-S	50gsm SMS in blue with 50gsm SMSreinforcement
GRI Fabric-Reinforced Surgicalgown	90-24XX-S	35gsm SMS in blue with 35gsm SMSreinforcement
Key for Surgical Gown Codes:
	Prefix	90= Surgical gown series
	Suffix - 1	First position represents "fabric"
		1 = 50gsm SMS
		2 = 35gsm SMS
	Suffix - 2	Second position represents "reinforcement"
		0 = None
		2 = Film reinforced
		3 = Fabric, 50gsm SMS
		4 = Fabric, 35gsm SMS
	Suffix - 3(x)	Third position represents "size"
		0 = Small
		1 = Medium
		2 = Large
		3 = Xlarge
		4 = XXLarge
	Suffix - 4(x)	Fourth position represents "length"
		0 = Standard
		1 = XLong
	Suffix - 5	Fifth position represents "packaging"
		S = Sterile

Indications for Use Product I ist· Sterile

: :

Page 4-2 of _4-4

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Indications for Use: Non-Sterile products

510(k) Number (if known): K102652

Device Name: Surgical Gowns

GRI's Non Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Non Reinforced Surgical Gowns meet Level 2 of the AAMI Liquid Barrier classifications. See Page 4-4 for product list.

GRI's Film Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, process ourgiour paticulate material. GRI's Film Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-4 for product list.

GRI's Fabric Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, protoc. or group particulate material. GRI's Fabric Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-4 for product list.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth R. Clamin-Will

Page 4-3 of 4-4

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K102652

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Product Name	Model Code	Primary Material
GRI Non-Reinforced Surgical gown	90-10XX	50gsm SMS in blue, Non-reinforced
	90-20XX	35gsm SMS in blue, Non-reinforced
GRI Film-Reinforced Surgical gown	90-12XX	50gsm SMS in blue with film reinforcement
	90-22XX	35gsm SMS in blue with film reinforcement
GRI Fabric-Reinforced Surgical gown	90-13XX	50gsm SMS in blue with 50gsm SMSreinforcement
	90-24XX	35gsm SMS in blue with 35gsm SMSreinforcement

Indications for Use Product List: Non-Sterile

Key for Surgical Gown Codes:

Prefix	90= Surgical gown series
Suffix - 1	First position represents "fabric"
	1 = 50gsm SMS
	2 = 35gsm SMS
Suffix - 2	Second position represents "reinforcement"
	0 = None
	2 = Film reinforced
	3 = Fabric, 50gsm SMS
	4 = Fabric, 35gsm SMS
Suffix - 3(x)	Third position represents "size"
	0 = Small
	1 = Medium
	2 = Large
	3 = Xlarge
	4 = XXLarge
Suffix - 4(x)	Fourth position represents "length"
	0 = Standard
	1 = XLong

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.