(361 days)
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No
The document describes a surgical gown and its material properties and testing, with no mention of AI or ML technology.
No
The device is a surgical gown intended to protect healthcare workers and patients from microorganisms, body fluids, and particulate matter, not to provide therapy.
No
This device is a surgical gown, which is a protective apparel worn by healthcare professionals. Its purpose is to create a barrier against microorganisms, body fluids, and particulate matter, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical surgical gown made of polyolefin/polypropylene SMMMS material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "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." This describes a physical barrier for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the materials and construction of a surgical gown, emphasizing its barrier properties and compliance with standards for protective apparel. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Reagents or assays
- Providing diagnostic results
- Use in a laboratory setting for testing
The device is a surgical gown, which falls under the category of protective medical apparel.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The SEJONG Level 3 Surgical Gowns is a non-reinforced design and available in 4 sizes ranging from medium to XX-large. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 and is equivalent to the predicate device. The test results demonstrate that the proposed device complies with the following standards by passing all applicable acceptance criteria and is equivalent to the predicate device.
Test Methodology: AATCC 42 Purpose: Assess resistance to water impact penetration Acceptance Criteria: Level 3, ≤1.0g Results: Pass
Test Methodology: AATCC 127 Purpose: Assess hydrostatic resistance Acceptance Criteria: Level 3, ≥50cm Results: Pass
Test Methodology: ASTM D5034 Purpose: Assess adequate tensile strength Acceptance Criteria: Length ≥ 30N Width ≥ 30N Results: Pass
Test Methodology: ASTM D5587 ASTM D5733 Purpose: Assess adequate tear resistance Acceptance Criteria: Length ≥ 10N Width ≥ 10N Results: Pass
Test Methodology: ASTM D1683 Purpose: Assess adequate seam strength Acceptance Criteria: Sleeve Seam: ≥ 30N Armhole Seam: ≥ 30N Shoulder Seam: ≥ 30N Results: Pass
Test Methodology: Bursting Strength ASTM D3787 ISO 13938-1 Purpose: Assess adequate bursting resistance Acceptance Criteria: ≥ 5.80 psi Results: Pass
Test Methodology: ISO 9073-10 Purpose: Assess acceptable lint and other particles generation in the dry state Acceptance Criteria: Log10 -6 Results: Pass
Test Methodology: ISO 10993-5 Purpose: Biocompatibility-cytotoxicity Acceptance Criteria: Non-cytotoxic Results: Pass
Test Methodology: ISO 10993-10 Purpose: Biocompatibility-irritation Acceptance Criteria: Non-irritating Results: Pass
Test Methodology: ISO 10993-10 Purpose: Biocompatibility-sensitization Acceptance Criteria: Non-sensitizing Results: Pass
Test Methodology: ISO 10993-7 Purpose: Verify acceptable sterilant residuals Acceptance Criteria: EO residual ≤ 4 mg/device ECH residual ≤ 9 mg/device Results: Pass
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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)
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)
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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 | |
(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 | |
(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,