← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K220435 # SEJONG Surgical Gown Soft (K220435) _Sejong Healthcare Co., Ltd. · FYA · Feb 10, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K220435 ## Device Facts - **Applicant:** Sejong Healthcare Co., Ltd. - **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md) - **Decision Date:** Feb 10, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended 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 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. ## Device Story Surgical gown; non-reinforced; constructed from blue polyolefin/polypropylene SMMMS nonwoven fabric. Worn by healthcare professionals in clinical settings to provide barrier protection against microorganisms, body fluids, and particulates. Available in sizes medium to XX-large; features neck/belt ties and knit cuffs. Provided sterile or as bulk non-sterile for third-party sterilization. Protects both patient and wearer; reduces cross-contamination risk. ## Clinical Evidence No clinical data. Bench testing only. Performance verified via AATCC 42 (water impact), AATCC 127 (hydrostatic pressure), ASTM D5034 (tensile), ASTM D5587/D5733 (tear), ASTM D1683 (seam strength), ASTM D3787/ISO 13938-1 (bursting), ISO 9073-10 (linting), 16 CFR 1610 (flammability), ISO 11737-2 (sterility), and ISO 10993 series (biocompatibility). ## Technological Characteristics Material: Polyolefin/polypropylene SMMMS nonwoven. Barrier: ANSI/AAMI PB70 Level 3. Sterilization: Ethylene Oxide (EtO) per ISO 11135. Flammability: CPSC 1610 Class 1. Design: Non-reinforced, set-in sleeves, knit cuffs. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Medline Level 3 Surgical Gown (Sirus Non-Reinforced) ([K190950](/device/K190950.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220435 Device Name SEJONG Surgical Gown Soft ### Indications for Use (Describe) 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. | 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." {3}------------------------------------------------ ## 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 {4}------------------------------------------------ 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 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. | 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 | | Intended
Use/Indications for
Use | The SEJONG Surgical Gown Soft
are 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 meet
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 SEJONG
Surgical Gown Soft have 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. | The Medline Level 2 Surgical
Gown (Eclipse Non Reinforced)
and Medline Level 3 Surgical
Gown (Eclipse Fabric
Reinforced), Medline Level 3
Surgical Gown (Sirus Non-
Reinforced & Sirus Fabric
Reinforced), Medline Level 3
Surgical Gown (Aurora Non
Reinforced & Aurora Fabric
Reinforced) are 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
Medline Level 2 Surgical Gown
and the Medline Level 3 Surgical
Gowns meet the respective level
requirements of ANSI/AAMI
PB70:2012 Liquid barrier
performance and classification of
protective apparel and drapes
intended for use in healthcare
facilities. The Medline Level 2
Surgical Gown and the Medline
Level 3 Surgical Gowns have been
validated using an ethylene oxide
(EtO) sterilization process. The
Medline Level 2 Surgical Gown
and the Medline Level 3 Surgical
Gowns are also sold as bulk
single-use, non-sterile, to
repackager/relabeler
establishments for further
packaging and sterilization using
the validated EtO sterilization
method according to ISO 11135-1
prior to being provided to the end
user | Same | | Regulation
number | 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- Reinforced
Neck and Belt Ties
Knit Cuffs
Set-in/Standard Sleeves | Available in Fabric Reinforced and
Non-Reinforced,
Hook and Loop Closure at neck
Belt Ties Knit Cuffs Transfer Tab
Raglan or Set-in/Standard Sleeves | Similar | | Size | Medium to XX-Large | Small to XXXX-Large | Similar | | Materials | Nonwoven SMMMS
polypropylene/Polyolefin | Nonwoven SMS
polypropylene/Polyolefin | Same | | Performance
Specifications | 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 | | Sterilization
Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same | | EO and ECH
Residuals | EO: not detectable
ECH: not detectable | Pass | Same | | Single Use vs.
Reusable | Single Use | Single Use | Same | | Flammability | Meets requirements of Flame
Resistant CPSC 1610 Class 1 | Meets requirements of Flame
Resistant CPSC 1610 Class 1 | Same | | Impact
Penetration
AATCC 42 | ≤1.0 g
AQL: 4% | ≤1.0 g
AQL: 4% | Same | | Hydrostatic
Pressure Test
AATCC 127 | ≥ 50cmH2O
AQL: 4% | ≥ 50cmH2O
AQL: 4% | Same | | Tensile strength
ASTM D5034-09 | Length ≥ 30N
Width ≥ 30N | Length ≥ 30N
Width ≥ 30N | Similar | | Tear resistance
ASTM D5587
ASTM D5733 | Length ≥ 10N
Width ≥ 10N | Length ≥ 10N
Width ≥ 10N | Similar | | Linting | Log10 $<$ 4 | Log10 $<$ 4 | Same | | Cytotoxicity
ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | Same | | Irritation
ISO 10993-10 | Non-irritating | Non-irritating | Same | | Sensitization
ISO 10933-10 | Non-sensitizing | Non-sensitizing | Same | {5}------------------------------------------------ {6}------------------------------------------------ ## VII.Non-Clinical Test Conclusion Non-clinical tests were con… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K220435](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K220435) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com