K Number

Device Name

DISPOSABLE SURGICAL GOWNS

Manufacturer

WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD

Date Cleared

2012-10-16

(267 days)

Product Code

FYA

Regulation Number

878.4040

Intended Use

Disposable Surgical Gowns, which are blue colored and EO sterilized, are indicated 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. It could achieve Level 3 Barrier Performance as per AAMI PB70:2003. It is for single use only.

Device Description

Disposable Surgical Gowns 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. Disposable Surgical Gowns are manufactured from three layers nonwoven fabric that is comprised of Spunbond (SMS) materials. Disposable Surgical Gowns are reinforced with an additional layer of SPP (Syndiotactic Polyprogylene) laminating film in the sleeve and body areas for higher barrier protection. The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K100971

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and barrier performance, with no mention of AI or ML.

Therapeutic

No
The device, disposable surgical gowns, is intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or therapeutically affect a disease or condition.

Diagnostic

The device description clearly states its purpose as protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. There is no mention of it being used to identify, monitor, or examine any medical condition or disease, which are typical functions of a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly indicates the device is a physical product (disposable surgical gowns made of fabric) and not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The description clearly states that the device is a "Disposable Surgical Gown" intended to be worn by operating room personnel for protection. It acts as a physical barrier.
Intended Use: The intended use is to protect both the patient and personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective function, not a diagnostic one.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.

The device described is a Class II medical device (based on the barrier performance level and intended use) that serves a protective function in a surgical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FYA

Device Description

The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description

Table v-1 General Description of Proposed Device
Proposed Device: Disposable Surgical Gowns
Material: SMS
Size: M, L, XL, XXL
Color: Blue
Style: Reinforced
Sterility: EO Sterilized

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F2407-06 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
AAMI PB70-2003 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
AATCC 42-2000 Water Resistance: Impact Penetration Test;
AATCC 127-2003 Water Resistance: Hydrostatic Pressure Test;
16 CFR Part 1610:2008 Standard for the Flammability of Clothing Textiles
ASTM D 5034 09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D 5733 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure
v. A STM D 1683 - 07 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
ISO 9073-10:2003 Textiles Test Methods for Nonwovens Part 10: Lint and Other Particles Generation in the Dry State
ASTM F 1868 02 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate - Part B - Isothermal Evaporative Resistance
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 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Resistance to Blood and Liquid Penetration: Level 3 per AAMI PB 70
Resistance to Tear: ≥20 N
Fire Protection: Class I
Free of toxic ingredients
the average value of coefficient of variation of linting is 6.2%
Free of Nonfast dyes
Burst strength: ≥40 Kpa
Tensile strength: ≥20 N
Disposable
Conforms to AATCC 42-2000, AATCC 127-2003, 16 CFR Part 1610:2008, ASTM D5034 - 09, ASTM D5733 - 99, ASTM D1683 - 07, ISO 9073 Part 10:2003, ASTM F1868 - 02
Biocompatibility: Conform to the requirement of ISO 10993 series Standards
Cytotoxicity: Not Found
Irritation: No intracutaneous reactivity
Sensitization: No delayed dermal contact sensitization
SAL: 106
Method: EO Sterilization
Validation: Conforms to ISO 11135
Package Integrity: Conforms to ISO 11607
EO Residual: Conforms to ISO 10993-7
Label and Labeling: Conforms to FDA Requirements

Predicate Device(s)

K100971

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

OCT
16
2012

Exhibit #2 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K120192

Date of Submission: September 25, 2012 1.

. मं Sponsor

Weihai Hongyu Nonwoven Fabric Products Co., Ltd. 9-1 Pudong Road, Area of Economy and Technique, Weihai. China, 264205 Establishment Registration Number: 3008489813 Contact Person: Yanfei Liu Position: Registration Manager Tel: + (86)-631-3636943 Fax: + (86)-631-3636910 Email: liuyanfei340@163.com

Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

Proposed Device Identification

Proposed Device Name: Disposable Surgical Gowns Proposed Device Model: M, L, XL, XXL Classification: II Product Code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General& Plastic Surgery

Intended Use Statement:

Predicate Device Identification 5.
Predicate device for Disposable Surgical Gowns 510(k) Number: K100971 Product Name: Hangzhou ATek Medical and Textile Surgical Gowns Manufacturer: Hangzhou ATek Medical and Textile Co. Ltd.

6. Device Description

The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description

Table v-1 General Description of Proposed Device
Proposed Device	Material	Size	Color	Style	Sterility
Disposable
Surgical Gowns	SMS	M	Blue	Reinforced	EO Sterilized
		L	Blue	Reinforced	EO Sterilized
		XL	Blue	Reinforced	EO Sterilized
		XXL	Blue	Reinforced	EO Sterilized

1 Description of Proposed Device

Non-Clinical Test Conclusion 7.

ASTM F2407-06 Standard Specification for Surgical Gowns Intended for Use in Healthcare > Facilities
AAMI PB70-2003 Liquid barrier performance and classification of protective apparel and drapes ﺮ intended for use in health care facilities
AATCC 42-2000 Water Resistance: Impact Penetration Test; >
AATCC 127-2003 Water Resistance: Hydrostatic Pressure Test; V
16 CFR Part 1610:2008 Standard for the Flammability of Clothing Textiles ア
ASTM D 5034 09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics ﺮ (Grab Test)
ASTM D 5733 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the ア Trapezoid Procedure
v. A STM D 1683 - 07 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
ISO 9073-10:2003 Textiles Test Methods for Nonwovens Part 10: Lint and Other Particles ﺮ Generation in the Dry State
ASTM F 1868 02 Standard Test Method for Thermal and Evaporative Resistance of Clothing ア Materials Using a Sweating Hot Plate - Part B - Isothermal Evaporative Resistance
ISO 10993-5:2009: Biological Evaluation of Medical Devices Part 5: Tests for in vitro ﺮ Cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin ア sensitization
ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for ﺮ development, validation and routing control of a sterilization process for medical devices

Item	Proposed Device	Predicate Device
Product Code	FYA	FYA
Regulation No.	21 CFR 878.4040	21 CFR 878.4040
Class	II	II
Intended Use	Disposable Surgical Gowns 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.	Disposable gowns are worn by operating room
personnel during surgical procedures to protect
both the surgical patient and OR personnel
from the transfer of body fluids and particulate
material.
Style	Reinforced	Reinforced and Non-reinforced
Size	M, L, XL, XXL	L, XL, XXL
Color	Blue	Unknown
Weight per square	45 g/m²	Unknown
	Thickness	0.16mm	Unknown
Physical Specifications	Resistance to Blood and Liquid Penetration	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70
	Resistance to Tear	≥20 N	≥20 N
	Fire Protection	Class I	Class I
	Features for Safe Use	Free of toxic ingredients
the average value of coefficient of variation
of linting is 6.2%
Free of Nonfast dyes	Free of toxic ingredients
Unknown
Free of Nonfast dyes
	Mechanical specifications	Burst strength	≥40 Kpa	≥40 Kpa
Tensile strength		≥20 N	≥20 N
Durability		Disposable	Disposable
	Performance Testing	Conform to
AATCC 42-2000
AATCC 127-2003
16 CFR Part 1610:2008
ASTM D5034 - 09
ASTM D5733 - 99
ASTM D1683 - 07
ISO 9073 Part 10:2003
ASTM F1868 - 02	Conform to
AATCC 42-2000
AATCC 127-2003
16 CFR Part 1610:2008
ASTM D5034 - 09
ASTM D5733 - 99
ASTM D1683 - 07
ISO 9073 Part 10:2003
ASTM F1868 - 02
			Material	SMS, SPP, Polypropylene, PE, Nylon, Polyester	SMS, Hydro-Entangled (Spunlace), SFT
			Biocompatibility	Conform to the requirement of ISO 10993 series Standards	Conform to the requirement of ISO 10993 series Standards
					Cytotoxicity
			Irritation	No intracutaneous reactivity	No intracutaneous reactivity
			Sensitization	No delayed dermal contact sensitization	No delayed dermal contact sensitization
		Sterilization	SAL	106	106
Method	EO Sterilization		EO Sterilization
Validation	Conforms to ISO 11135		Conforms to ISO 11135
Package Integrity	Conforms to ISO 11607		Conforms to ISO 11607
EO Residual	Conforms to ISO 10993-7		Conforms to ISO 10993-7
	Label and Labeling	Conforms to FDA Requirements	Conforms to FDA Requirements

8. Summary of Comparison

E2-3

Exhibit #2 510(k) Summary

. .

E2-4

1:2-5

9. Substantially Equivalent Conclusion

・

The proposed devices, Disposable Surgical Gowns, are determined to be Substantially Equivalent (SE) to the predicate device, Hangzhou ATek Medical and Textile Surgical Gowns (K100971), in respect of safety and effectiveness. 1 ・

Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 1 6 2012

Weihai Hongyu Nonwoven Fabric Products Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai, 200237 China

Re: K120192

Trade/Device Name: Disposable Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 25, 2012 Received: October 1, 2012

· Dear Ms. Hong:

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.

Page 2- Ms. Hong

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Antion V. Van

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

Indications for Use

510(k) Number: Device Name: Disposable Surgical Gowns Proposed device model: M, L, XL and XXL

Indications for Use:

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

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. Clamie. William

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

K120192 510(k) Number: