The Jincheng Surgical Gown is a single use, sterile or none sterile (sterile before use) item that is intended to be used in operation room as a protective covering, for operating room staff, from the transferring of body fluids and particulates.

Gowns provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Device Description

The Jincheng Surgical Gowns are an open back gown manufactured from nonwoven fabric that the fibres are mechanically bonded together. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They come with three different types of materials (SMS polypropylene fabric, Spunlace fabric, and SFT fabric) and four different design styles (regular, reinforced, regular with guider, and reinforced with guider). Therefore there are total eight different models involved in this submission. They are: Jincheng SMS Gowns (SMS Reinforced Gown, SMS Reinforced Gown with Guider), Jincheng Spunlace Gowns (Spunlace Regular Gown, Spunlace Regular Gown with Guider, Spunlace Reinforced Gown, Spunlace Reinforced Gown with Guider), Jincheng SFT Gowns (SFT Gown, SFT Gown with Guider). Each design has four different sizes: Medium (M), Large (L), Extra Large (XL), and Extra Extra Large (XXL). All gowns come with sterile and non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

AI/ML Overview

The provided text describes the acceptance criteria and study for a Surgical Gown, not a medical device in the typical sense of AI/software or diagnostic tools. Therefore, several of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.

Here's the information extracted from the provided 510(k) summary for the "Jincheng Surgical Gowns":

1. Table of Acceptance Criteria and Reported Device Performance

Description	Acceptance Criteria (Standard)	Reported Device Performance
Cytotoxicity	ISO10993-5 (No Toxic Effect)	No Toxic Effect
Skin Irritation and Sensitization	ISO 10993-10 (No Effect)	No Effect
Hydrostatic Pressure: Water Resistance	AATCC Test Method 127: 1998 (Hydrostatic Pressure Test)	Met requirements per AATCC Test Method 127: 1998
Impact Penetration Test : Water Resistance	AATCC 42: 2007 (Water Resistance: Impact Penetration Test)	Met requirements per AATCC 42: 2007
Breaking Strength	ASTM D5034: 2008 (Standard Test Method for Breaking Strength and Elongation)	Met requirements per ASTM D5034
Elmendorf Tear	ASTM - D5734-95:2001 (Standard Test Method for Tearing Strength of Nonwoven Fabrics)	In-house method similar to ASTM - D5734-95:2001, met requirements
Flammability	16 CFR 1610 (Flammability Test Method - CPSC CS-191-53)	Met requirements per 16 CFR 1610
Lint	ISO 9073-10 (Lint and Other Particles Generation in the Dry State)	Met requirements per ISO 9073-10
Sterilization (for non-sterile gowns sold to OEMs)	ISO 11135 (EtO sterilization)	For OEMs to perform; validation to ISO 11135
Sterilization (for sterile gowns sold directly)	ISO 11135 (EtO sterilization validation)	Validation to ISO 11135
Overall Safety and Effectiveness	Meets requirements of predefined acceptance criteria and intended uses	"Safe and effective, and its performance meets the requirements of its predefined acceptance criteria and intended uses."

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

Sample Size: Not explicitly stated for each test. The submission implies that sufficient samples were tested to meet the standards.
Data Provenance: The tests were conducted by Hangzhou Jincheng Medical Supplier Manufacture Co., Ltd in China. The data would be considered retrospective as it was collected before the 510(k) submission.

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 surgical gowns is established through adherence to recognized international and national consensus standards for materials and performance, not expert human interpretation.

4. Adjudication method for the test set

Not applicable. The performance is objectively measured against established standards, not through human adjudication of results.

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 physical product (surgical gown), not an AI/software device.

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

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

7. The type of ground truth used

The ground truth used is based on consensus standards and regulations (e.g., ISO, AATCC, ASTM, CFR) which define the acceptable physical, mechanical, and biological properties for surgical gown materials and performance.

8. The sample size for the training set

Not applicable. This is a physical product (surgical gown), not an AI/machine learning model that requires a training set.

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

Not applicable. This is a physical product (surgical gown), not an AI/machine learning model.

Summary

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K102692

Section 5: 510k Summary

MAR 1 1 2011

Section 5: 510(k) Summary:

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

Submitter & Foreign Manufacture Identification

Hangzhou Jincheng Medical Supplier Manufacture Co., Ltd 202 Zhangshan Road, Renhe Town, Yuhang District Hangzhou, Zhejiang Province, China 311107 Tel: 86-571-86396888 EXT 8205 Submitter's FDA Registration Number: N/A

US Agent and Contact Person

Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com

Date of Summary: June 22, 2010

Name of Device: Surgical Gown Classification Name: Gown, Surgical Product Code: FYA Regulation Number: 807.4040

Predicate Device Information:

(1) K052550, "International Medsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical Gown Inc" located in Schaumburg, Illinois.
(2) K070431, Welmed Surgical Gowns, manufactured by Welmed, Inc. located in Grayslake, Illinois.

Device description:

Section 5: 510k Summary Section 5 p 1

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K102692

Section 5: 510k Summary

reinforced with guider). Therefore there are total eight different models involved in this submission. They are:

Jincheng SMS Gowns

. SMS Reinforced Gown
. SMS Reinforced Gown with Guider

Jincheng Spunlace Gowns

Spunlace Regular Gown .
Spunlace Regular Gown with Guider .
. Spunlace Reinforced Gown
Spunlace Reinforced Gown with Guider .

Jincheng SFT Gowns

. SFT Gown
SFT Gown with Guider .

Each design has four different sizes: Medium (M), Large (L), Extra Large (XL), and Extra Extra Large (XXL).

All gowns come with sterile and non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Intended Use:

Gowns provided as sterile and non-sterile.

Comparison to Predicate Devices

Hangzhou Jincheng Surgical Gowns are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

(1) K052550, "International Medsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical Gown Inc" located in Schaumburg, Illinois.
(2) K070431, Welmed Surgical Gowns, manufactured by Welmed, Inc. located in Grayslake, Illinois.

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Section 5: 510k Summary

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

Description	Our Device	Predicate Device 1(K070431)	Predicate Device 2(K052550)
Indication forUse	Are used as protectivecovering for operating roomstaff, from the transferring ofbody fluids and particulates.	Same	Same
Basic Design	Full length, constructed withraglan sleeves, neck closures,and waist closures.	Same	Same
AdditionalFeatures	Regular and reinforced	Information not available	Regular and reinforced
Materials/size	Non-woven (SMS, Spunlace,SFT)/various size	Non-woven (SMS,SPP)/various size	Non-woven (variousmaterial)/various size
Single Use	Yes	Yes	Information not available
Sterile	Both sterile and non sterile	Both sterile and non sterile	Information not available

Table 5.1: Comparison of Intended Use, Design, and Material

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Section 5: 510k Summary

The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Jincheng Surgical Gowns met all relevant requirements in the test standards, and are comparable to the predicate device.

Details of the test procedures and results can be found in Sections 15 (Biocompatibility) and 18 (Performance Testing-Bench).

Description	Our Device	Predicate Device 1(K070431)	Predicate Device 2(K052550)
Cytotoxicity	No Toxic Effect(ISO10993-5)	No Toxic Effect(ISO10993-5)	No Toxic Effect(ISO10993-5)
SkinIrritation andSensitization	No Effect(ISO 10993-10)	No Effect(ISO 10993-10)	No Effect(ISO 10993-10)
HydrostaticPressure:WaterResistance	AATCC Test Method 127: 1998:Water Resistance: HydrostaticPressure Test	Same	Same
ImpactPenetrationTest : WaterResistance	AATCC 42: 2007: WaterResistance: Impact PenetrationTest	Same	Same
BreakingStrength	ASTM D5034: 2008: StandardTest Method for BreakingStrength and Elongation ofTextile Fabrics (Grab Test)	Same	Same
ElmedorfTear	In house method similar toASTM - D5734-95:2001	ASTM - D5734-95:2001Standard Test Method forTearing Strength ofNonwoven Fabrics byFalling-Pendulum(Elmendorf) Apparatus	N/A
Flammability	16 CFR 1610: Flammability TestMethod (CPSC CS-191-53)Standard for Flammability ofClothing Textiles	Same	Same
Lint	ISO 9073-10: Lint and OtherParticles Generation in the DryState	Same	IST 160.1

Table 5.2: Comparison of Biocompatibility and Performance Testing

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Section 5: 510k Summary

More details of non-clinical tests are summarized in Section 15 and Section 18.

A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:

Jincheng Surgical Gown meet requirements per AATCC Test Method 127: 1998. AATCC 42: 2007, ASTM D5034, 16 CFR 1610, ISO 9073-10, ISO 10993-5, and ISO 10993-10. It is safe and effective, and it's performance meets the requirements of its predefined acceptance criteria and intended uses.

A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Substantial Equivalent Statement

Based on the comparison of intended use, design, materials, and performance, our Jincheng Surgical Gowns are substantial equivalent to its predicate devices.

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

Hangzhou Jincheng Medical Supplier Manufacture Company, Limited C/O Mr. Chengyu Shen Manton Business and Technology Services 5 Carcy Street Pennington, New Jersey 08534

MAR 1 1 2011

Re: K102692

Trade/Device Name: Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: February 17, 2011 Received: February 18, 2011

Dear Mr. Shen:

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- Mr. Shen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that IFDA 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
James Rotch
for

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

Enclosure

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Section 4: Indications for Use

Material	Design	Sterilization	Model Name	Sizes
SMS	Reinforced	Sterile	SG74100	M, L, XL, XXL
		Non-sterile	SG74700	M, L, XL, XXL
SMS	Reinforced with Guider	Sterile	SG78100	M, L, XL, XXL
		Non-sterile	SG78700	M, L, XL, XXL
Spunlace	Regular	Sterile	SG80100	M, L, XL, XXL
		Non-sterile	SG80700	M, L, XL, XXL
Spunlace	Regular with Guider	Sterile	SG82100	M, L, XL, XXL
		Non-sterile	SG82700	M, L, XL, XXL
Spunlace	Reinforced	Sterile	SG84100	M, L, XL, XXL
		Non-sterile	SG84700	M, L, XL, XXL
Spunlace	Reinforced with Guider	Sterile	SG88100	M, L, XL, XXL
		Non-sterile	SG88700	M, L, XL, XXL
SFT	Gown	Sterile	SG94100	M, L, XL, XXL
		Non-sterile	SG94700	M, L, XL, XXL
SFT	Gown with Guider	Sterile	SG98100	M, L, XL, XXL
		Non-sterile	SG98700	M, L, XL, XXL

The gowns involved in this submission are summarized in the Table below:

Gowns provided as sterile and non-sterile.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

K102692

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Elijah T. Clemmons Williams
	(Division Sign-Off)
	Division of Anesthesiology, General Hospital
	Infection Control, Dental Devices

510(k) Number:	K102692
----------------	---------

Section 4: Indication Section 4 page 2Section 4: Indication Section 4 page

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.