(372 days)
Not Found
No
The device description and performance studies focus on material properties and barrier performance, with no mention of AI or ML.
No
The device is a surgical gown intended to protect healthcare workers from the transfer of microorganisms, body fluids, and particulate matter, not to provide therapeutic treatment.
No
The device is a surgical gown, which is personal protective equipment intended to protect healthcare workers and patients, not to diagnose medical conditions.
No
The device is a physical surgical gown, not a software application. The description focuses on material properties, barrier performance, and physical testing.
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 gowns are "to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids and particulate matter." This describes a barrier protection device, 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, construction, and barrier performance of the gowns. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies listed are related to the physical properties and barrier performance of the gowns (sterilization, shelf-life, toxicity, water resistance, tear resistance, etc.). There are no studies related to diagnostic accuracy or the analysis of biological specimens.
IVD devices are specifically designed to be used in vitro (outside the body) to test samples like blood, urine, or tissue to detect diseases, conditions, or infections. Surgical gowns, while medical devices, serve a different purpose of providing a physical barrier.
N/A
Intended Use / Indications for Use
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
The Unico Global Level 3 Surgical Gowns meets the requirements of ANSV/AAMI PB70:2012 level 3 liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are single use, disposable medical devices; provided sterile. Non-sterile gowns are to be sold to re-packager/relabeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The subject device offers the two material models which are Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE). The two models use different base materials but use the same PE film layer in addition to the fabric. They have slightly different design elements in neck, body, and belt straps.
The Unico Global Level 3 Surgical Gowns (Film-reinforced SMS and PP+PE) have been tested according to AATCC Test Method 127:2017, ANSI/AAMI PB70:2012, and ISO 811, and meet the AAMI Level 3 barrier level protection for a surgical gown.
The Unico Global Level 3 Surgical Gowns are single use that will be provided in both sterile and non-sterile packaging configurations and offer a variety of sizes ranging from medium to XX-large.
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
healthcare professionals, healthcare facilities
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)
The following tests were performed on the subject device and the test results support that the subject device met the requirement for each test. Especially the performance test results support that the subject device satisfied the requirement of level 3 surgical gown.
- Sterilization Validation: ISO 11135-1:2014, Acceptance Criteria: Sterility Assurance Level: 10-6, Results: Pass
- Shelf-Life Validation: ASTM F1980, ASTM F88, ASTM F1929, ISO 10993-7, ISO 11737-2, Acceptance Criteria: Bioburden test: ISO 11737-1 'Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products' Sterility test: No microbial growth Seal Strength Test (Blister): Maximum seal strength (N/15mm) ->>1.2 Dye Penetration test: No leakage, Results: Pass
- Acute systemic toxicity: ISO 10993-11, Acceptance Criteria: Adverse no effects occurring at any time within 72h after single, multiple or continuous exposures of a test sample for 24h., Results: Pass
- Sensitization & Irritation Tests: ISO 10993-10, Acceptance Criteria: Sensitization test: The observations are scored between 0 (no visible change) to 3 (intense erythema and swelling). More than grade 0 indicates sensitization. Irritation tests: The test result obtained is a score between 0 and 8 calculated from the various observations, considered as negligible (0-0.4), slight (0.5-1.9), moderate (2-4.9), or severe (5-8)., Results: Pass
- Water Resistance: Impact Penetration: AATCC Test Method 42 and is in accordance with ANSI/AAMI PB70, Acceptance Criteria: Visual Penetration: None seen Amount of Penetration (g) : ≤ 1.0 g, Results: Pass
- Water Resistance: Hydrostatic Pressure: AATCC Test Method 127:2017, ANSI/AAMI PB70:2012, and ISO 811:2018, Acceptance Criteria: Pressure: ≥ 50 cm, Results: Pass
- Tear Resistance: ASTM D5587, Acceptance Criteria: No acceptance criteria currently exist for this test., Results: Pass
- Basis Weight: ASTM D3776, Acceptance Criteria: Test articles should be weighed, and the basis weight should be calculated as the mass divided by the area. all should weigh the same., Results: Pass
- Sterilant Gas Residue Analysis: ANSI/AAMI/ISO 10993-7, Acceptance Criteria: Maximum levels of sterilant residuals: ETO
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
December 10, 2021
Unicoglobal, Inc. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, California 92620
Re: K203539
Trade/Device Name: Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: October 26, 2021 Received: December 1, 2021
Dear Priscilla Chung:
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.
For Clarence W. Murray, III, PhD 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
2
Indications for Use
510(k) Number (if known) K203539
Device Name
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
Indications for Use (Describe)
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
The Unico Global Level 3 Surgical Gowns meets the requirements of ANSV/AAMI PB70:2012 level 3 liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are single use, disposable medical devices; provided sterile. Non-sterile gowns are to be sold to re-packager/relabeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
| 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
(K203539)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Dec 7, 2021
1. 510K Applicant / Submitter:
Unicoglobal, Inc. #904. Woolim Pangyo W-City 9-22, Pangyo-Ro 255bion-Gil Bundang-gu, Seongnam City Gyeonggido, 13486 Republic of Korea
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- . Proprietary Name: Unico Global level 3 Surgical Gown (Film-reinforced SMS) Unico Global Level 3 Surgical Gown (PP+PE)
- Common Name: Surgical Gown .
- Classification: Class II (21 CFR 878.4040) ●
- Product Code: FYA .
4. Predicate Device
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced) Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced) Medline Level 3 Surgical Gown (Sirus Non-Reinforced) Medline Level 3 Surgical Gown (Sirus Fabric Reinforced) Medline Level 3 Surgical Gown (Aurora Non -Reinforced & Aurora Fabric Rein
(K190950) by Medline Industries, Inc.
4
5. Description:
The subject device offers the two material models which are Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE). The two models use different base materials but use the same PE film layer in addition to the fabric. They have slightly different design elements in neck, body, and belt straps.
The Unico Global Level 3 Surgical Gowns (Film-reinforced SMS and PP+PE) have been tested according to AATCC Test Method 127:2017, ANSI/AAMI PB70:2012, and ISO 811, and meet the AAMI Level 3 barrier level protection for a surgical gown.
The Unico Global Level 3 Surgical Gowns are single use that will be provided in both sterile and non-sterile packaging configurations and offer a variety of sizes ranging from medium to XX-large.
6. Indications for Use
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) 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 Unico Global Level 3 Surgical Gowns meets the respective level requirements of ANSI/AAMI PB70:2012 level 3 liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are single use, disposable medical devices; provided sterile or nonsterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 11135-1.
7. Comparison of Technological characteristics:
The predicate device is as follows:
K 190950 by Medline Industries, Inc.
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced) Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced) Medline Level 3 Surgical Gown (Sirus Non-Reinforced) Medline Level 3 Surgical Gown (Sirus Fabric Reinforced) Medline Level 3 Surgical Gown (Aurora Non -Reinforced & Aurora Fabric Rein)
5
8. Comparison Chart
| Device
| Characteristic | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Device Name | Unico Global level 3 Surgical | |||
| Gown (Film-reinforced SMS) | ||||
| Unico Global Level 3 Surgical | ||||
| Gown (PP+PE) | Medline Level 2 Surgical Gown | |||
| (Eclipse Non-Reinforced) | ||||
| Medline Level 3 Surgical Gown | ||||
| (Eclipse Fabric Reinforced) | ||||
| Medline Level 3 Surgical Gown (Sirus | ||||
| Non-Reinforced) | ||||
| Medline Level 3 Surgical Gown (Sirus | ||||
| Fabric Reinforced) | ||||
| Medline Level 3 Surgical Gown (Aurora | ||||
| Non - Reinforced & Aurora Fabric | ||||
| Reinforced | - | |||
| 510K # | K203539 | K190950 | - | |
| Manufacturer | Unico Global VN Co., Ltd. | Medline Industries, Inc. | - | |
| Product Code | FYA | FYA | Same | |
| Indications for | ||||
| Use | The Unico Global Level 3 | |||
| Surgical Gown (Film-reinforced | ||||
| SMS) and Unico Global Level 3 | ||||
| Surgical Gown (PP+PE) 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 Unico Global Level 3 | ||||
| Surgical Gowns meets the | ||||
| respective level requirements of | ||||
| ANSI/AAMI PB70:2012 level 3 | ||||
| liquid barrier performance and | ||||
| classification of protective | ||||
| apparel and drapes intended for | ||||
| use in health care facilities. |
The Unico Global Level 3
Surgical Gown (Film-reinforced
SMS) and Unico Global Level 3
Surgical Gown (PP+PE) are
single use, disposable medical
devices; provided sterile or non-
sterile. Non-sterile gowns are to
be sold to re-packager/re-labeler
establishments for ethylene oxide
(EtO) sterilization according to
ISO 11135-1 prior to marketing to
the end users and sterile surgical
gowns are to be sold directly to
users after EtO sterilization
validation to ISO 11135-1. | 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 | |
| Color | Blue | Blue | Same | |
| Design Feature | Film-
reinforced
SMS
Velcro hook
and loop with
neck straps at
neck
Single use
Belt Straps
Knit Cuffs
Transfer Tab
Set-in Sleeves | PP+PE
Neck straps
Single use
Belt straps
Knit cuffs
Set-in Sleeves | Available in Fabric Reinforced and Non
Reinforced
Velco hook and loop for neck closure
Single Use
Belt Straps
Knit Cuffs
Transfer Tab
Raglan or Set-in/Standard Sleeves | Similar |
| Size | Medium to XX-Large | | Small to XXXX-Large | Similar |
| Materials | Film (PE) Reinforced Nonwoven SMS
Polypropylene/Polyethylene | | Nonwoven SMS
Polypropylene/Polyolefin | Different |
| Performance
Specifications | Level 3 PB70 Barrier Protection | | Level 2 PB70 Barrier Protection
Level 3 PB70 Barrier Protection | Same |
| Prescription
vs. OTC | OTC | | OTC | Same |
| Contact
Durations | Surface, Intact, >1.2 Dye Penetration test: No leakage | Pass |
| Acute systemic
toxicity | ISO 10993-11 | Adverse no effects occurring at any
time within 72h after single, multiple
or continuous exposures of a test
sample for 24h. | Pass |
| Sensitization &
Irritation Tests | ISO 10993-10 | Sensitization test: The
observations are scored between 0
(no visible change) to 3 (intense
erythema and swelling). More
than grade 0 indicates
sensitization. Irritation tests: The test result
obtained is a score between 0 and
8 calculated from the various
observations, considered as
negligible (0-0.4), slight (0.5-1.9),
moderate (2-4.9), or severe (5-8). | Pass |
| Water Resistance:
Impact Penetration | AATCC Test Method 42 and is in
accordance with ANSI/AAMI PB70 | Visual Penetration: None seen
Amount of Penetration (g) : ≤ 1.0 g | Pass |
| Water Resistance:
Hydrostatic Pressure | AATCC Test Method 127:2017,
ANSI/AAMI PB70:2012, and ISO
811:2018 | Pressure: ≥ 50 cm | Pass |
| Tear Resistance | ASTM D5587 | No acceptance criteria currently exist
for this test. | Pass |
| Basis Weight | ASTM D3776 | Test articles should be weighed, and
the basis weight should be calculated
as the mass divided by the area. all
should weigh the same. | Pass |
| Sterilant Gas Residue Analysis | ANSI/AAMI/ISO 10993-7 | Maximum levels of sterilant residuals:
ETO