The SEJONG Surgical Gown Soft is sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The SEJONG Surgical Gown Soft meets the Level 3 requirements of ANSI/AAMI PB70:2012. Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The SEIONG Surgical Gown Soft has been validated using ethylene oxide (EtO) sterilization process. The SEJONG Surgical Gown Soft is also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EO sterilization method according to ISO 11135 prior to being provided to the end user.

Device Description

The SEJONG Level 3 Surgical Gowns is a non-reinforced design and available in 4 sizes ranging from medium to XX-large. Below Table provides model number of the Sejong Surgical Gown Soft. The chest and sleeve critical zones, as well as the overall body, are constructed from a blue polyolefin/polypropylene SMMMS (Spunbound, meltblown, meltblown, spunbound). Sejong Surgical Gown Soft has been tested according to ANSI/AAMI PB70:2012 and meets and AAMI Level 3 barrier level protection for a surgical gown. Sejong Surgical Gown Soft is nonreinforced, single use, disposable medical device that will be provided in both a sterile packaging configuration and a variety of sizes.

AI/ML Overview

This document describes the premarket notification (510(k)) for the SEJONG Surgical Gown Soft, manufactured by Sejong Healthcare Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Medline Level 3 Surgical Gown (Sirus Non-Reinforced) (K190950).

As this is a 510(k) submission for a surgical gown, the "device" in question is not an AI/software medical device, but rather a physical apparel. Therefore, many of the typical acceptance criteria and study components associated with AI/software performance (such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, and human-in-the-loop performance) are not applicable here. The "performance" of this device is assessed through non-clinical laboratory testing to ensure it meets established safety and performance standards for surgical apparel.

Here's the breakdown of the information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are presented in a table under Section VII. "Non-Clinical Test Conclusion."

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
AATCC 42	Assess resistance to water impact penetration	Level 3, ≤1.0g	Pass
AATCC 127	Assess hydrostatic resistance	Level 3, ≥50cm	Pass
ASTM D5034	Assess adequate tensile strength	Length ≥ 30NWidth ≥ 30N	Pass
ASTM D5587ASTM D5733	Assess adequate tear resistance	Length ≥ 10NWidth ≥ 10N	Pass
ASTM D1683	Assess adequate seam strength	Sleeve Seam: ≥ 30NArmhole Seam: ≥ 30NShoulder Seam: ≥ 30N	Pass
Bursting StrengthASTM D3787ISO 13938-1	Assess adequate bursting resistance	≥ 5.80 psi	Pass
ISO 9073-10	Assess acceptable lint and other particles generation in the dry state	Log10 < 4	Pass
16 CFR Part 1610	Flammability testing	Class 1	Pass
ISO 11737-2	Sterility assurance	10-6	Pass
ISO 10993-5	Biocompatibility - cytotoxicity	Non-cytotoxic	Pass
ISO 10993-10	Biocompatibility - irritation	Non-irritating	Pass
ISO 10993-10	Biocompatibility - sensitization	Non-sensitizing	Pass
ISO 10993-7	Verify acceptable sterilant residuals	EO residual ≤ 4 mg/deviceECH residual ≤ 9 mg/device	Pass

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

The document specifies non-clinical tests were conducted. The sample size for these tests is not explicitly stated in the provided text. However, for physical product testing like surgical gowns, "samples" refer to individual gowns or material swatches taken from gowns, and these tests are typically conducted in a laboratory setting.

Data Provenance: The manufacturing company, Sejong Healthcare Co., Ltd., is located in Republic of Korea. The non-clinical tests would have been performed in a laboratory, likely in Korea or by a certified testing facility adhering to international standards (e.g., ISO, ASTM, AATCC). These are prospective tests conducted specifically for this submission.

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

Not applicable. For physical product performance tests (like barrier properties, strength, flammability, biocompatibility), "ground truth" is established by adherence to established, quantitative international and national standards (e.g., ANSI/AAMI PB70:2012, ISO standards, ASTM standards, CFR regulations). There is no "expert" interpretation or consensus involved in determining the outcome of these objective laboratory tests. The tests themselves provide the "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3. Testing is objective and quantitative, not qualitative, so no adjudication is required.

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 section pertains to AI/software performance studies. The device is a surgical gown.

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

Not applicable. This section pertains to AI/software performance studies. The device is a surgical gown.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the "ground truth" for the performance of the surgical gown is based on objective measurements and quantitative results from validated laboratory tests, adhering to established industry and regulatory standards (e.g., AATCC, ASTM, ISO, 16 CFR Part 1610, ANSI/AAMI PB70:2012). For example, barrier performance is "ground-truthed" by measuring the amount of water impact penetration (in grams) or hydrostatic pressure (in cmH2O), and these numerical results are compared against the specific pass/fail criteria defined by the standards. Biocompatibility is "ground-truthed" by established biological assays that yield results like "Non-cytotoxic," "Non-irritating," or "Non-sensitizing."

8. The sample size for the training set

Not applicable. This concept relates to machine learning models. The specified "device" is a physical surgical gown, not an AI algorithm.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

February 10, 2023

Sejong Healthcare Co., Ltd. % Seohee Kwon RA Manager K-Bio Solutions 201 South 4th St. Suite 727 San Jose, California 95112

Re: K220435

Trade/Device Name: SEJONG Surgical Gown Soft Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: January 12, 2023 Received: January 19, 2023

Dear Seohee Kwon:

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.

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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 medical devices and radiation-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

Bifeng Qian, M.D., 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

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Indications for Use

510(k) Number (if known) K220435

Device Name SEJONG Surgical Gown Soft

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 K220435

The following information is provided in accordance with 21 CFR 807.92 for the premarket 510(k) summary:

Submitter's Information I.

Company: Sejong Healthcare Co., Ltd. Address: 1502-1, Tongil-ro, Paju-eup,
Paju-si, Gyeonggi-do, 10836, Republic of Korea ●
Tel : 82-31-942-1700
Fax: 82-31-942-1801 ●

510(k) Submission Correspondent: Jian Park, RA Manager K-Bio Solutions jian.park(@)kbiotechsolutions.com Tel: 82-2-597-2700, USA: 408-750-7843

Date Prepared: January 25th, 2023

II. Device Information

Trade Name of Device: Sejong Surgical Gown Soft
Common Name of Device: Gown, Surgical ●
Regulation Name: Surgical Apparel ●
Review Panel: General Hospital ●
Regulation Number: 21 CFR 878.4040
Regulatory Class: Class II ●
Product Code: FYA
. Model Number: GSGW971 (SEJONG Surgical Gown Soft, Size: Medium) GSGW972 (SEJONG Surgical Gown Soft, Size: Large) GSGW973 (SEJONG Surgical Gown Soft, Size: X-Large) GSGW975 (SEJONG Surgical Gown Soft, Size: XX-Large)

III. Predicate Device

Medline Level 3 Surgical Gown (Sirus Non-Reinforced) ●
510(k) number: K190950 ●
Manufacturer: Medline Industries, Inc.
Product Code: FYA ●
Regulation Number: 21 CFR 878.4040
The predicate device has not been subject to a design-related recall. ●

IV. Intended Use/Indications for Use

The SEJONG Surgical Gown Soft is sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The SEJONG Surgical Gown Soft meets the Level 3 requirements of ANSI/AAMI PB70:2012. Liquid barrier performance and classification of

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protective apparel and drapes intended for use in healthcare facilities. The SEJONG Surgical Gown Soft has been validated using ethylene oxide (EtO) sterilization process. The SEJONG Surgical Gown Soft is also sold as bulk single-use, non-sterile, to re-packager /re-labeler establishments for further packaging and sterilization using the validated EO sterilization method according to ISO 11135 prior to being provided to the end user.

V. Device Description

No.	Device Name	Model Number	Size
1	SEJONG Surgical Gown Soft	GSGW971	Medium
2	SEJONG Surgical Gown Soft	GSGW972	Large
3	SEJONG Surgical Gown Soft	GSGW973	X-Large
4	SEJONG Surgical Gown Soft	GSGW975	XX-Large

Device Names, Model Numbers of the Sejong Surgical Gown Soft

VI. Technological Characteristic Comparison Table

Category		(K190950)	Comparison
Product Name	Sejong Surgical Gown Soft	Medline Level 3 Surgical Gown(Sirus Non-Reinforced)	N/A
510(k)Reference	K220435	K190950	N/A
Product Owner	Sejong Healthcare Co., Ltd.	Medline Industries, Inc.	N/A
Category		< Predicate Device >(K190950)	Comparison
IntendedUse/Indications forUse	The SEJONG Surgical Gown Softare sterile, single use surgicalapparel intended to be worn byhealthcare professionals to helpprotect both the patient and thehealthcare worker from the transferof microorganisms, body fluids,and particulate matter. TheSEJONG Surgical Gown Soft meetthe Level 3 requirements ofANSI/AAMI PB70:2012. Liquidbarrier performance andclassification of protective appareland drapes intended for use inhealthcare facilities. The SEJONGSurgical Gown Soft have beenvalidated using ethylene oxide(EtO) sterilization process. TheSEJONG Surgical Gown Soft isalso sold as bulk single-use, non-sterile, to re-packager /re-labelerestablishments for furtherpackaging and sterilization usingthe validated EO sterilizationmethod according to ISO 11135prior to being provided to the enduser.	The Medline Level 2 SurgicalGown (Eclipse Non Reinforced)and Medline Level 3 SurgicalGown (Eclipse FabricReinforced), Medline Level 3Surgical Gown (Sirus Non-Reinforced & Sirus FabricReinforced), Medline Level 3Surgical Gown (Aurora NonReinforced & Aurora FabricReinforced) are sterile, single usesurgical apparel intended to beworn by healthcare professionalsto help protect both the patient andthe healthcare worker from thetransfer of microorganisms, bodyfluids, and particulate matter. TheMedline Level 2 Surgical Gownand the Medline Level 3 SurgicalGowns meet the respective levelrequirements of ANSI/AAMIPB70:2012 Liquid barrierperformance and classification ofprotective apparel and drapesintended for use in healthcarefacilities. The Medline Level 2Surgical Gown and the MedlineLevel 3 Surgical Gowns have beenvalidated using an ethylene oxide(EtO) sterilization process. TheMedline Level 2 Surgical Gownand the Medline Level 3 SurgicalGowns are also sold as bulksingle-use, non-sterile, torepackager/relabelerestablishments for furtherpackaging and sterilization usingthe validated EtO sterilizationmethod according to ISO 11135-1prior to being provided to the enduser	Same
Regulationnumber	21 CFR 878.4040	21 CFR 878.4040	Same
Product Code	FY A	FY A	Same
Color	Blue	Blue	Same
Category		< Predicate Device >(K190950)	Comparison
Design Features	Available in Fabric Non- ReinforcedNeck and Belt TiesKnit CuffsSet-in/Standard Sleeves	Available in Fabric Reinforced andNon-Reinforced,Hook and Loop Closure at neckBelt Ties Knit Cuffs Transfer TabRaglan or Set-in/Standard Sleeves	Similar
Size	Medium to XX-Large	Small to XXXX-Large	Similar
Materials	Nonwoven SMMMSpolypropylene/Polyolefin	Nonwoven SMSpolypropylene/Polyolefin	Same
PerformanceSpecifications	Level 3 PB70 Barrier Protection	Level 3 PB70 Barrier Protection	Same
Prescription vs.OTC	OTC	OTC	Same
Contact Durations	Surface, Intact, < 24 hours	Surface, Intact, < 24 hours	Same
Sterile vs. Non-Sterile	Sterile	Sterile	Same
SterilizationMethod	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Same
EO and ECHResiduals	EO: not detectableECH: not detectable	Pass	Same
Single Use vs.Reusable	Single Use	Single Use	Same
Flammability	Meets requirements of FlameResistant CPSC 1610 Class 1	Meets requirements of FlameResistant CPSC 1610 Class 1	Same
ImpactPenetrationAATCC 42	≤1.0 gAQL: 4%	≤1.0 gAQL: 4%	Same
HydrostaticPressure TestAATCC 127	≥ 50cmH2OAQL: 4%	≥ 50cmH2OAQL: 4%	Same
Tensile strengthASTM D5034-09	Length ≥ 30NWidth ≥ 30N	Length ≥ 30NWidth ≥ 30N	Similar
Tear resistanceASTM D5587ASTM D5733	Length ≥ 10NWidth ≥ 10N	Length ≥ 10NWidth ≥ 10N	Similar
Linting	Log10 $<$ 4	Log10 $<$ 4	Same
CytotoxicityISO 10993-5	Non-cytotoxic	Non-cytotoxic	Same
IrritationISO 10993-10	Non-irritating	Non-irritating	Same
SensitizationISO 10933-10	Non-sensitizing	Non-sensitizing	Same

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VII.Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications and is equivalent to the predicate device. The test results demonstrate that the proposed device complies

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with the following standards by passing all applicable acceptance criteria and is equivalent to the predicate device.

TestMethodology	Purpose	Acceptance Criteria	Results
AATCC 42	Assess resistance towater impactpenetration	Level 3, ≤1.0g	Pass
AATCC 127	Assess hydrostaticresistance	Level 3, ≥50cm	Pass
ASTM D5034	Assess adequatetensile strength	Length ≥ 30NWidth ≥ 30N	Pass
ASTM D5587ASTM D5733	Assess adequatetear resistance	Length ≥ 10NWidth ≥ 10N	Pass
ASTM D1683	Assess adequateseam strength	Sleeve Seam: ≥ 30NArmhole Seam: ≥ 30NShoulder Seam: ≥ 30N	Pass
Bursting StrengthASTM D3787ISO 13938-1	Assess adequatebursting resistance	≥ 5.80 psi	Pass
ISO 9073-10	Assess acceptablelint and otherparticles generationin the dry state	Log10 < 4	Pass
16 CFR Part 1610	Flammability testing	Class 1	Pass
ISO 11737-2	Sterility assurance	10-6	Pass
ISO 10993-5	Biocompatibility-cytotoxicity	Non-cytotoxic	Pass
ISO 10993-10	Biocompatibility-irritation	Non-irritating	Pass
ISO 10993-10	Biocompatibility-sensitization	Non-sensitizing	Pass
ISO 10993-7	Verify acceptablesterilant residuals	EO residual ≤ 4 mg/deviceECH residual ≤ 9 mg/device	Pass

VIII. Clinical Test Conclusion

No clinical study is included in this submission.

IX. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K190950.

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.