K Number

Device Name

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

Manufacturer

Xiamen Probtain Medical Techology Co., Ltd

Date Cleared

2023-03-07

(118 days)

Product Code

FYA

Regulation Number

878.4040

Intended Use

The Disposable Surgical Gowns are 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 matter. This is a single use, disposable device, provided sterile.

Device Description

The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

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

K212591

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 matter, not to treat or alleviate a disease or condition.

Diagnostic

Explanation: The device is a disposable surgical gown intended to protect personnel and patients from microorganisms and fluids during surgical procedures. Its purpose is protective, not diagnostic.

SaMD (Software as a Medical Device)

The device description clearly indicates it is a physical product (surgical gowns made of SMMS nonwoven material and cotton) and the performance studies are related to material properties and biological evaluation, not software functionality.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the gowns are for protecting surgical patients and personnel from the transfer of microorganisms, body fluids, and particulate matter. This is a physical barrier function, not a diagnostic one.
Device Description: The description focuses on the materials, construction, size, and sterilization of the gown. There is no mention of any components or functions related to analyzing samples from the human body.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
Performance Studies: The performance studies listed are related to the physical properties of the gown (biocompatibility, flammability, strength, barrier performance, lint generation, seam strength), not diagnostic accuracy or analytical performance.

The device described is a medical device, specifically a surgical gown, intended for use as a protective barrier in a healthcare setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FYA

Device Description

The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).
This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

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 / operating room

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)

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:

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 10993-7:2008(R) 2012 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D5587-15. Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
ISO9073-10-2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
ASTM D1683/D1683M-17 (2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics

Key results included:

Seam strength: PASS (77.54 N average from 10 samples)
Breaking strength: PASS (MD: 156.87N, CD: 125.20N average from 10 samples)
Tear strength: PASS (MD: 66.34N, CD: 38.44N average from 10 samples)
Lint and other generation in the dry state: PASS (2.6 Log10(particle count) average from 10 samples)
Flammability: PASS (Class I)
Water Penetration Resistance: PASS (≤1.0g)
Static hydrostatic resistance: PASS (≥50 cm)
EO and ECH sterilization residual: PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d)
Cytotoxicity: PASS (Non-Cytotoxic)
Irritation: PASS (Non-Irritating)
Sensitization: PASS (Non-Sensitizing)

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

Seam strength: 77.54 N (Average result from 10 samples)
Breaking strength: MD: 156.87N, CD: 125.20N (Average result from 10 samples)
Tear strength: MD: 66.34N, CD: 38.44N (Average result from 10 samples)
Lint and other generation in the dry state: 2.6 Log10(particle count) (Average result from 10 samples)
Flammability: Class I
Water Penetration Resistance: ≤1.0g
Static hydrostatic resistance: ≥50 cm
EO sterilization residual: ≤ 4mg/d
ECH sterilization residual: ≤ 9mg/d

Predicate Device(s)

K212591

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

March 7, 2023

Xiamen Probtain Medical Technology Co., Ltd % Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai 200122, China

Re: K223401

Trade/Device Name: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 1, 2023 Received: March 1, 2023

Dear Jarvis Wu:

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).

Sincerelv.

Allan Guan -S

For Bifeng Qian, MD, 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K223401

Device Name

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

510(K) Summary

K223401

Document prepared date: 2023/03/01

A. Applicant:

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen,Fujian,361100,China Contact Person: Jianli Kang +86-592-7557106 Tel: Fax: +86-592-7199255 Email: kangjianli@probtain.com

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com

B. Device:

Trade Name: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) Common Name: Surgical Gown Model: S,M,L,XL,XXL,XXXL

Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FY A Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K212591 Disposable Surgical Gown Suzhou JaneE Medical Technology Co., Ltd.

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD

4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

D. Intended use of the device/ Indications for Use:

E. Device Description:

This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

Device	Predicate Device	Proposed Device	Comparison
Manufacturer	Suzhou JaneE Medical
Technology Co., Ltd.	XIAMEN PROBTAIN
MEDICAL TECHNOLOGY
CO., LTD
510K number	K212591	K223401
Product Name	Disposable Surgical Gown	Disposable Surgical Gowns	Same
Product Code	FYA	FYA	Same
Classification	Class II Device, FYA (21
CFR878.4040)	Class II Device, FYA
(21 CFR878.4040)	Same
Intend use	The Disposable Surgical
Gowns are 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
matter. This is a single use,
disposable device, provided
sterile.	The Disposable Surgical Gowns
are 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
matter. This is a single use,
disposable device, provided
sterile.	Same
Material
Composition	Polyolefin (Polypropylene)
SMS nonwoven	Sleeve/body/belt (SMMS non-
woven)
Cuff (Cotton)	Similar
Sterility	Sterile	Sterile	Same
Sterilization	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Same
Method
Sterilization
Residuals	EO ≤ 4mg/day
ECH ≤ 9mg/day	EO ≤ 4mg/day
ECH ≤ 9mg/day	Same
Color	Blue	Blue	Same
Size	M,L,XL,TL	S、M、L、XL、XXL、
XXXL	Similar. No
effect on
safety or
efficacy
Weight per
square(g)	Critical Area: 87.8g/m²
Non-Critical Area: 45.12g/m²	44g/m²	Similar. No
effect on
safety or
			efficacy.
Tensile
(Breaking
strength)
D5034-09	MD: 16.18 lbs (72N)
CD: 13.26 lbs (59N)	MD: 156.87N
CD: 125.20N	Similar. No
effect on
safety or
efficacy.
Both passed
performance
tests.
Tearing
Strength
ASTM
D5587-15	MD:22.25 lbs (99 N)
CD:18.20 lbs (81N)	MD: 66.34N
CD: 38.44N	Similar. No
effect on
safety or
efficacy.
Both passed
performance
tests.
Seam Strength
ASTM
D16383M-17	Sleeve Seam:68.3N
Side Seam:69.7N
Belt Seam:71N	77.54N	Similar. No
effect on
safety or
efficacy.
Both passed
performance
tests.
Hydrostatic
Pressure(cm)
AATCC-127	>50 cm	>50 cm	Same
Water Impact
(g) AATCC-42	≤1.0 g	≤1.0 g	Same
Resistance to
blood and liquid
penetration	Level 3 AAMI PB70	Level 3 AAMI PB70	Same
Biocompatibility	Under the conditions of the
study, the device extract was
not cytotoxic.	Under the conditions of the
study, the device extract was
not cytotoxic	Same

F. Comparison with predicate device

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fuijan,361100, China

| Under the conditions of the
study, the non-polar and polar
device extracts were not found
to be an irritant. Under
conditions of the study, the
non-polar and polar device
extracts were not found to be a
sensitizer. | Under the conditions of the
study, the non-polar and polar
device extracts were not found
to be an irritant. Under
conditions of the study, the
non-polar and polar device
extracts were not found to be a
sensitizer. |

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Different analysis:

The proposed surgical gowns are similar to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength, breaking strength and seam strength are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/ D1683M-17(2018) respectively, and met the requirements of the standard.

Under the conditions of each study, the proposed surgical gown is non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.

G. Summary of Non-Clinical Test Results

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

A ISO 10993-7:2008(R) 2012 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals

CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles; A
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of
Textile Fabrics (Grab Test);F

ASTM D5587-15. Standard Test Method for Tearing Strength of Fabrics by Trapezoid > Procedure;

AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective > Apparel and Drapes Intended For Use In Health Care Facilities.

A ISO9073-10-2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state

ASTM D1683/D1683M-17 (2018) Standard Test Method for Failure in Sewn Seams of A Woven Fabrics

Test Item	Test standard	Acceptance Criteria	Result
Seam strength
ASTM D1683M-17
Standard Test Method
for Failure in Sewn	The test was performed
In accordance with
ASTM D1683M-17
Standard. Test Method	≥30N(7lbf)
per standard
F2407-20 for level 3	PASS
77.54 N
Seams of Woven Fabrics.	for Seam Strength of Textile Fabrics (Grab Test) to evaluate Failure in Sewn Seams of the test sample.		(Average result from 10 samples)
Breaking strength
ASTM D5034-09
(2017) Standard Test
Method for Breaking
Strength and
Elongation of Textile
Fabrics (Grab Test)	The test was performed
In accordance with
D5034-09 (2017) .
Standard. Test Method
for Breaking Strength
and Elongation of Textile
Fabrics (Grab Test) to
evaluate the
breaking strength of the
test sample.	≥30N(7lbf)
per standard
F2407-20 for level 3	PASS
MD: 156.87N
CD: 125.20N
(Average result from 10 samples)
Tear strength(N)
ASTM D5587-15,
Standard Test Method
for Tearing Strength of
Fabrics by Trapezoid
Procedure	The test was performed
in accordance with
ASTM D5587:
2015(2019) Standard
Test Method for Tearing
Strength of Fabrics by
Trapezoid Procedure to
evaluate
the tearing strength of the
test sample.	≥10N	PASS
MD: 66.34N
CD: 38.44N
(Average result from 10 samples)
Lint and other
generation in the
dry state
ISO 9073- 10:2003(E)	The test was performed
in accordance with ISO
9073-10: 2003 Textiles-
Test Methods for
Nonwovens-Part 10: Lint
and Other Particles
Generation in the Dry
State to evaluate the
linting of the test
sample.	Log10(particle count)