K Number

Device Name

Disposable Surgical Gown

Manufacturer

Shandong Zhushi Pharmaceutical Group Co., Ltd

Date Cleared

2021-08-12

(171 days)

Product Code

FYA

Regulation Number

878.4040

Intended Use

The Disposable 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 (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.

Device Description

The Disposable Surgical Gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of polyester elastic closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown

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

K170762

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier performance of a surgical gown, with no mention of AI or ML.

Therapeutic

No.
The device is a surgical gown intended for protective purposes for personnel and patients, not for treating a disease or condition.

Diagnostic

Explanation: The device is a Disposable Surgical Gown, which is a barrier protection device used to prevent the transfer of microorganisms and body fluids. Its intended use and description focus on protective barrier properties, not on diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description and performance studies clearly indicate a physical, disposable surgical gown, not a software product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gown is for protecting surgical patients and personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
Device Description: The description focuses on the physical components and construction of the gown, designed for barrier protection.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on the physical properties and barrier performance of the gown (impact penetration, hydrostatic resistance, tensile strength, etc.), as well as sterility and biocompatibility. These are relevant to a protective medical device, not an IVD.

In summary, the Disposable Surgical Gown is a medical device intended for physical protection during surgery, not for performing diagnostic tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FYA

Device Description

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 during surgical procedures

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

Non-Clinical Test Conclusion: The proposed device was tested and conformed to the related recognized standards and the requirements stated in the "Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes" dated on August, 1993.
Based on the 6-180 ASTM F2407-06 (Reapproved 2013), the subject device has been conducted the test as following:
AATCC 42-2013 Water Resistance: Impact Penetration Test
AATCC 127-2014 Water Resistance: Hydrostatic Pressure Test
ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Texile Fabrics (Grab Test)
ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D1683-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
ASTM F1868-17(2017) Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
ISO 9073-10:2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
16 CFR Part 1610(a) Standard for The Flammability of Clothing Textiles
USP42-NF37 Bacterial Endotoxins Test
ISO 11737-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Key Metrics

AATCC 42 - Impact Penetration: 70 cm for critical zone
ASTM D5034 - Tensile strength: Machine direction mean: 21.95 lbf; Cross direction mean: 14.41 lbf.
ASTM D5587 - Tear resistance: Farbic direction A mean: 5.09 lbf; Farbic direction B mean: 3.10 lbf;
ASTM D1683 - Seam strength: Shoulder: 10.8 lbf; Arm opening: 6.4 lbf; Sleeve: 10.2 lbf;
ISO 9073-10 - Side A (outside) Index for Particulate Matter (IPM): 2.25; Side B (inside) Index for Particulate Matter (IPM): 2.85; Side A&B Index for Particulate Matter (IPM): 2.64
ASTM 2407 - Evaporative resistance: Critical zone: 953.8 g/m²/24hrs; Non-critical zone: 930.2 g/m²/24hrs
16 CFR Pat 1610 - Flame spread: Class 1, Non Flammable
USP42-NF37 - Bacterial Endotoxins:

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 12, 2021

Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210510

Trade/Device Name: Disposable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: May 12, 2021 Received: May 12, 2021

Dear Boyle 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian -S

For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K210510

Device Name Disposable Surgical Gown

Indications for Use (Describe)

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

K210510

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

1.0 Submitter's information

Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Contact: Mr. Junhui Zhu Phone Number: 86-530-7150111 Fax number: 86-530-7150111 Date of Preparation: Aug.01, 2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device information

Trade name: Disposable Surgical Gown Common name: Surqical qown Classification name: Gown, Surgical Model(s): XS, S, M, L, XL, XXL, XXXL, XXXXL

3.0 Classification

Production code: FYA Regulation number: 21CFR 878.4040 Classification: Class II Surgical apparel Panel:

4.0 Predicate device information

Manufacturer: Cardinal Health 200, LLC Device: Cardinal Health™ Non-Reinforced Surgical Gown 510(k) number: K170762

5.0 Intended Use/Indication for Use Statement

6.0 Device description

Table 3 - General Comparison
Item	Proposed device	Predicated device	Remark
Product Code	FYA	FYA	Identical
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Identical
Class	II	II	Identical
Product name	Disposable Surgical Gown	Cardinal Health™ Non-Reinforced Surgical Gown	Similar
510(k) No.	K210510	K170762	Different
Models	XS, S, M, L, XL, XXL, XXXL, XXXXL	M-S, M, L, XL, XXL	Similar
Intended
Use/Indications for
Use	The Disposable 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 (AAMI PB70).
The Disposable Surgical Gowns are
single use, disposable medical
devices, provided sterile.	Cardinal Health™
Non-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	Similar

7.0Technological Characteristic Comparison Table

		facilities (AAMI PB70). The
		Cardinal Health™ Non-
		Reinforced Surgical Gowns are
		single use, disposable medical
		devices; provided sterile and
		non-sterile.
Composite	Neck Closure: Hook and Loop
Belt Ties Knit Cuffs
Transfer Tab	Neck Closure: Hook and Loop
Belt Ties Knit Cuffs
Transfer Tab	Identical
Material	Polyolefin (Polypropylene) SMS
nonwoven	Polyolefin (Polypropylene) SMS
nonwoven	Identical
Color	Blue	Blue	Identical
Sterility	Sterile	Non-Sterile and sterile	* Gap 1
Sterilization method	EO	EO	Identical
Shelf life	2 years	No identified	* Gap 2
Single Use	Yes	Yes	Identical
Impact Penetration	70 cm for critical zone	65-92 cm	* Gap 3
Tensile strength	Machine direction mean: 21.95 lbf;
Cross direction mean: 14.41 lbf.	MD mean: 21.57 lbf; CD mean:
13.6 lbs	* Gap 4
Tear resistance	Fabric direction A mean: 5.09 lbf;
Fabric direction B mean: 3.10 lbf;	MD mean: 3.47 lbf; CD mean:
5.63 lbs	* Gap 5
Flame spread	Class 1, Non Flammable	Class 1, Non Flammable	Identical
Resistance to blood
and liquid
penetration	Level 3 per PB70	Level 3 per PB70	Identical
Cytotoxicity	Under the condition of the test, no
potential cytotoxicity	Under the condition of the test,
no potential cytotoxicity	Identical
Irritation
Sensitization	Under the condition of the test, no
irritation and sensitization	Under the condition of the test,
no irritation and sensitization	Identical

* Gap analysis:

Gap 1: the proposed device is provided sterile, the predicate device has two types sterile and non sterile, this difference does not create additional risks to the device. Gap 2, the predicate device was not claimed clear shelf life, while the proposed device defined 2 years, the proposed device performed its shelf life study and verified its 2 years shelf life, the difference does not raise additional risk for safety and effectiveness. Gap 3-5, the two devices have some little deviation in product performance, but the difference in the performance test result does not raise additional questions for safety and effectiveness.

8.0 Non-Clinical Test Conclusion

The proposed device was tested and conformed to the related recognized standards and the requirements stated in the "Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes" dated on August, 1993.

Based on the 6-180 ASTM F2407-06 (Reapproved 2013), the subject device has been conducted the test as following:

AATCC 42-2013 Water Resistance: Impact Penetration Test

AATCC 127-2014 Water Resistance: Hydrostatic Pressure Test

ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Texile Fabrics (Grab Test)

ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure

ASTM D1683-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics

ASTM F1868-17(2017) Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate

ISO 9073-10:2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state

16 CFR Part 1610(a) Standard for The Flammability of Clothing Textiles

USP42-NF37 Bacterial Endotoxins Test

ISO 11737-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

| Test

Methodology	Purpose	Acceptance Criteria	Results
AATCC 42	Impact
Penetration	Level 3, ≤1.0g	70 cm for critical zone
ASTM D5034	Tensile strength	Machine direction mean:
≥18 lbf;
Cross direction mean:
≥12 lbf.	Machine direction mean:
21.95 lbf;
Cross direction mean: 14.41
lbf.
ASTM D5587	Tear resistance	Farbic direction A mean:
≥4.0 lbf;
Farbic direction B mean:
≥2.5 lbf;	Farbic direction A mean:
5.09 lbf;
Farbic direction B mean:
3.10 lbf;
ASTM D1683	Seam strength	Shoulder: ≥8.5 lbf;
Arm opening: ≥5.5 lbf;
Sleeve: ≥8.5 lbf;	Shoulder: 10.8 lbf;
Arm opening: 6.4 lbf;
Sleeve: 10.2 lbf;
ISO 9073-10	Side A (outside)	Index for Particulate
Matter (IPM): ≤2.5	Index for Particulate Matter
(IPM): 2.25
	Side B (inside)	Index for Particulate
Matter (IPM): ≤3.0	Index for Particulate Matter
(IPM): 2.85
	Side A&B	Index for Particulate
Matter (IPM): ≤3.0	Index for Particulate Matter
(IPM): 2.64
ASTM 2407	Evaporative
resistance	Critical zone: ≥850
g/m²/24hrs
Non-critical zone: ≥850
g/m²/24hrs	Critical zone: 953.8
g/m²/24hrs
Non-critical zone: 930.2
g/m²/24hrs
16 CFR Pat	Flame spread	Class 1, Non Flammable	Class 1, Non Flammable

1610
USP42-NF37
Bacterial
Endotoxins