Jiangsu Guangda's 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.

This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

Device Description

Jiangsu Guangda's Disposable XLarge Reinforced Surgical Gowns, Model Number GD-SG-01, are made from SMS fabrics and PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs to provide user protection in surgical settings.

AI/ML Overview

The provided document describes the acceptance criteria and the performance of a surgical gown (Jiangsu Guangda Surgical Gown, Model Number GD-SG-01), not a diagnostic device. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of device submission.

Here is the information derived from the provided text, primarily focusing on the requested table and the study details that are relevant for a surgical gown:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance (Jiangsu Guangda Surgical Gown, Model Number GD-SG-01)
Liquid Barrier Performance:
Hydrostatic Pressure (AATCC Test Method 127)	Has met acceptance criteria (Predicate)	All were >20
Impact Penetration (AATCC Test Method 42)	Has met acceptance criteria (Predicate)	All were ≤1
Resistance by Blood-Borne Pathogen (ASTM- F1671)	Unknown (Predicate)	All were ≤1
Resistance by Synthetic Blood (ASTM- F1670)	Has met acceptance criteria (Predicate)	Passed
Physical Specifications:
Breaking Strength (ASTM-D5034)	Has met acceptance criteria (Predicate)	Passed
Tearing Strength (ASTM-D5733)	Has met acceptance criteria (Predicate)	Passed
Flammability Test Method (16 CFR 1610)	Has met acceptance criteria (Predicate)	Class I
Seam Strength (ASTM-D1683)	Has met acceptance criteria (Predicate)	Passed
Biocompatibility:
Cytotoxicity (ISO 10993-5)	Has met acceptance criteria (Predicate)	Passed
Irritation (ISO 10993-10)	Has met acceptance criteria (Predicate)	Passed
Sensitization (ISO 10993-10)	Has met acceptance criteria (Predicate)	Passed
Sterilization:
EO and ECH Residual	Unknown (Predicate)	Conforms to ISO 10993-7

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

Sample size: Not explicitly stated as a numerical value for each test. The document mentions "All were >20" for Hydrostatic Pressure and "All were ≤1" for Impact Penetration and Resistance by Blood-Borne Pathogen, indicating multiple samples were tested. For other tests like Resistance by Synthetic Blood, Breaking Strength, Tearing Strength, Seam Strength, Cytotoxicity, Irritation, and Sensitization, the result is simply "Passed." The exact number of units or replicates tested is not detailed.
Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. This type of bench testing is typically conducted in a laboratory setting.

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

Not applicable. The "ground truth" for this device involves established engineering and biological performance standards, not expert clinical interpretation. The performance is determined by standardized laboratory tests.

4. Adjudication method for the test set

Not applicable. Performance is determined by meeting objective criteria in standardized tests, not by expert 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 surgical gown, not an AI-powered diagnostic device involving human readers.

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

Not applicable. This is a physical medical device (surgical gown), not an algorithm or software device.

7. The type of ground truth used

The "ground truth" (or more accurately, the standard for evaluation) used for the surgical gown is established by international and national standards for medical device performance, specifically for surgical apparel. These standards include:
- ASTM-F2407-06 (Standard Specification for Surgical Gowns)
- AAMI/ANSI/ISO 10993 series (Biological evaluation of medical devices)
- ANSI/AAMI PB70:2003 (Liquid Barrier Performance and Classification)
- AATCC Test Method 127 and 42 (Water Resistance)
- ASTM-F1671 and F1670 (Resistance to Penetration by Blood-Borne Pathogen/Synthetic Blood)
- ASTM-D5034, D5733, D1683 (Tensile, Tearing, Seam Strength)
- CPSC CS-191-53 Flammability Test Method (16 CFR 1610)

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. (See answer to #8).

Summary

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K121152

Section 5: 510(k) Summary

April 12, 2012 1. Preparation Date:

DEC 1 2 2012

2. Submitted by:

Jiangsu Guangda Medical Material Co., Ltd. 18 BaoChang Road North, LiBao Town, Haian County, Jiangsu Province, China 226631 Owner/Operator #: 10023676 Registration Number: 3006847952

3. Contact Person/Prepared by:

Darren Reeves (804) 307-7706 Phone: Fax: (866) 393-4954 Email: dreeves@dpdconline.com

4. Device Identification:

Trade Name: Surgical Gown Common Name: Gown, Surgical Classification: Surgical Apparel, FYA, Class 2 (878.4040)

GRI MEDICAL Surgical Gowns (K102652) 5. Predicate Device:

6. Device Description:

7. Intended Use:

Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01, 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.

This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

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8. Comparison to Predicate:

The following table shows similarities and differences between the predicate identified in Section 5 of this summary. There are no significant differences between the Jiangsu Guangda's Gowns, Model Number GD-SG-01, and their respective predicate products.

	Item	Proposed Device: Jiangsu Guangda's Gowns,Model Number GD-SG-01	Predicate Device: GRI MEDICALSurgical Gowns (K102652)
	Product Code	FYA, Class II	FYA, Class II
	Intended Use	Jiangsu Guangda's Reinforced Surgical Gowns arenon-sterile, single use surgical gowns intended toprotect surgical patients and operating roompersonnel from the transfer of microorganisms,body fluids, and particulate material.This product may be sterilized using EthyleneOxide (EO) following the validation and routinecontrol under ANSI/AAMI/ISO 11135.	GRI's Non Reinforced, Film Reinforced, andFabric Reinforced Surgical Gowns aresterile and non-sterile, single use surgicalgowns intended to protect surgical patientsand operating room personnel from thetransfer of microorganisms, body fluids,and particulate material.
	Style	Reinforced	Reinforced and non-reinforced
	Durability	Disposable	Disposable
	Size	XL	Various
	Color	Blue	Various
	Material	SMS and PE+PP two layer compound	Same
	Weight per square	45 g/m²	50 g/m²
	Label and Labeling	Conforms to FDA Requirements	Unknown
Liquid Barrier Performance:ANSI/AAMI PB70	Hydrostatic Pressure: AATCCTest Method 127	All were >20	Has met acceptance criteria
	Impact Penetration: AATCC TestMethod 42	All were ≤1	Has met acceptance criteria
	Resistance by Blood-BornePathogen: ASTM- F1671	All were ≤1	Unknown
	Resistance by Synthetic Blood:ASTM- F1670	Passed	Has met acceptance criteria
Physical Specifications	Breaking Strength: ASTM-D5034	Passed	Has met acceptance criteria
	Tearing Strength: ASTM- D5733	Passed	Has met acceptance criteria
	Flammability Test Method (16CFR 1610)	Class I	Has met acceptance criteria
	Seam Strength: ASTM- D1683	Passed	Has met acceptance criteria
Biocompatibility:ISO 10993-1	Cytotoxicity: ISO 10993-5	Passed	Has met acceptance criteria
	Irritation: ISO 10993-10	Passed	Has met acceptance criteria
	Sensitization: ISO 10993-10	Passed	Has met acceptance criteria
Sterilization	Method	Although sold non-sterile, gowns can be EOSterilized	Unknown
	EO and ECH Residual	Conforms to ISO 10993-7	Unknown

Jiangsu Guangda Medical Material Co., Ltd. Document Number K121152 S3.1

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9. Summary of Testing:

The information in the Premarket Notification on safety and efficiency supports a finding of substantially equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, material, design and testing methods.

Standard or Guidance	Data Generated	Relevant Section ofSubmission
ASTM-F2407-06 Standard Specification for Surgical Gowns intended for Use in Healthcare Facilities	Biocompatibility Testing Evaluation	15
AAMI/ANSI/ISO 10993-1:2003(E), Biological evaluation ofmedical devices -- Part 1: Evaluation and testing	Biocompatibility TestingEvaluation	15
AAMI/ANSI/ISO 10993-5:2009, Biological evaluation of medicaldevices -- Part 5: Tests for In Vitro cytotoxicity	Cytotoxicity	15
AAMI/ANSI/ISO 10993-10:2010, Biological evaluation ofmedical devices -- Part 10: Tests for irritation and sensitization	Skin Irritation, intra-cutaneous reactivity &sensitization	15
ANSI/AAMI PB70:2003, Liquid Barrier Performance andClassification of protective apparel and drapes intended for usein health care facilities	Barrier Performance	18
AATCC Test Method 127-2007&2008 Hydrostatic Pressure:Option 2	Water Resistance	18
AATCC Test Method 42-2007 Impact Penetration: Type II	Water Resistance	18
ASTM-F1671:2007 Standard Test Method for Resistance ofMaterials Used in Protective Clothing to Penetration by Blood-Borne Pathogens	Resistance to Penetration	18
ASTM-F1670:2008 Standard Test Method for Resistance ofMaterials Used in Protective Clothing to Penetration bySynthetic Blood	Resistance to Penetration	18
ASTM-D5034:1995 Standard Test Method for BreakingStrength and Elongation of Textile Fabrics (Grab Test)	Tensile Strength	18
ASTM-D5733:1999 Standard Test Method for Tearing Strengthof Nonwoven Fabrics by Trapezoid Procedure	Tearing Strength	18
ASTM-D1683:2007 Standard Test Method for Failure in SewnSeams of Woven Apparel Fabrics	Seam Strength Test	18
CPSC CS-191-53 Flammability Test Method (16 CFR 1610)Standard for Flammability of Clothing Textiles	Flammability	18

Test Data Provided in this Submission

The predicate, GRI MEDICAL Surgical Gowns (K102652) met acceptance criteria for bench testing including biocompatibility, hydrostatic pressure, impact penetration, Resistance to Penetration by Synthetic Blood, flammability, and strength via tensile, tear and seam strength.

10. Conclusion:

The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is is demonstrated through intended use, materials, design and testing methods.

Similarities/Differences of the proposed device when compared to the predicate: The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.

Jiangsu Guangda Medical Material Co., Ltd. Document Number K121152 S3.1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 12, 2012

Mr. Darren Reeves Jiangsu Guangda Medical Material Company, Limited 7305 Hancock Village Drive, Suite 109 CHESTERFIELD VA 23832

Re: K121152

Trade/Device Name: Jiangsu Guangda Surgical Gown, Model Number GD-SG-01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 30, 2012 Received: December 4, 2012

Dear Mr. Reeves:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a reward your 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 conninered pror to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic Act (110.) that to neviee, subject to the general controls provisions of the Act. The 1 ou may, therefore, market 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 addition. I lease noter a, 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 IT your device is blassified (been to be subjecting major regulations affecting your device can be may be subject to additions, 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 - Mr. Reeves

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/Safety/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthong Dr. ant

Anthony D. Watson, B.A., M.S., M.B.A. 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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Image /page/5/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo includes an emblem on the left and the text "Department of Health and Human Services" on the right. The emblem appears to be a stylized representation of an eagle or other bird.

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

K121157

Indications for Use

510(k) Number (if known): K121152

Device Name: Jiangsu Guangda Surgical Gown, Model Number GD-SG-01

Indications for Use:

This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

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 F. Claverie
2012.12.11 18:08:11 -05'00'

General Hospital Anesthesfolog Infection Control, Denta

510(k) Number: K121152

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.