← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K210147 # Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield (K210147) _Unicoglobal, Inc. · FXX · Dec 22, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K210147 ## Device Facts - **Applicant:** Unicoglobal, Inc. - **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md) - **Decision Date:** Dec 22, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile. ## Device Story Four-layer flat-pleated surgical mask; includes ear loops or tie strings; optional polyethylene terephthalate face shield with anti-glare strip. Materials: polypropylene spunbond (outer/insertion/inner layers), polypropylene melt-blown (filter). Used in clinical settings by healthcare personnel and patients; provides physical barrier against microorganisms, body fluids, and particulates. Single-use, disposable, non-sterile. Protects wearer and patient from cross-contamination; reduces exposure to blood/body fluids. ## Clinical Evidence Bench testing only. Performance testing included: Particle Filtration Efficiency (PFE) ≥98% (ASTM F2299); Synthetic Blood Penetration (160 mmHg, ASTM F1862/ISO 22609); Differential Pressure <60 mmH2O/cm² (EN 14683/ASTM F2100); Flammability (Class 1, 16 CFR 1610); Bacterial Filtration Efficiency (BFE) ≥98% (ASTM F2101). Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-sensitizing, and non-irritating. ## Technological Characteristics Four-layer construction: polypropylene spunbond (outer/insertion/inner) and polypropylene melt-blown (filter). Nose piece: PVC-coated zinc wire. Ear loops: cotton/spandex. Tie strings: polypropylene. Face shield: polyethylene terephthalate film. ASTM F2100 Level 3 compliant. Non-sterile, single-use, disposable. ## 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 - 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask ([K191355](/device/K191355.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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 22, 2021 Unicoglobal, Inc. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, California 92620 Re: K210147 Trade/Device Name: Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 16, 2021 Received: November 18, 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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) K210147 #### Device Name Unico High Performance Surgical Mask & Unico High Performance Surgical Mask with Face Shield #### Indications for Use (Describe) The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection to reduce potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile. Type of Use (*Select one or both, as applicable*) | | |------------------------------------------------------------------------------------------------| | | CONTINUE ON A SEPARATE PAGE IF NEEDED # 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 (K210147) This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: Dec 12, 2021 #### 1. Submitter: Unicoglobal, Inc. #904, Woolim Pangyo W-City 9-22, Pangyo-Ro 255bion-Gil Bundang-gu, Seongnam City Gyeonggido, 13486 Republic of Korea Tel. +82-70-7865-0026 Contact Person: Mr. Lim Jong Il #### 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 High Performance Surgical Mask Unico High Performance Surgical Mask with Face Shield - Common Name: Surgical Mask - · Classification Name: Surgical Mask (21 CFR 878.4040) - · Regulatory Class: II - Product Code: FXX ## 4. Predicate Device - · Name of Device: 3MTM High Fluid-Resistant Surgical Mask and 3MTM High Fluid-Resistant Procedure Mask (K191355) by 3M Health Care - Common Name: Surgical Mask {4}------------------------------------------------ - · Classification Name: Surgical Mask (21 CFR 878.4040) - · Regulatory Class: II - Product Code: FXX #### 5. Device Description: The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are composed of four layers and are flat-pleated and offers both ear loops and tie strings types. The mask materials consist of outer layer (Polypropylene Spunbond), insertion layer (Polypropylene Spunbond) and inner layer (Polypropylene Spunbond), and middle layer filter (polypropylene melt-blown). Each mask contains ear loops or tie strings to secure the mask over the user's mouth and face with nose piece to firmly fit over the nose. The mask may also contain a face shield made from a polyethylene terephthalate film, with an anti-glare strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face to prevent potential exposure to blood and body fluids. The mask(s) are single use, disposable device(s), provided non-sterile. #### 8. Indications for Use The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile. #### 9. Comparison of Technological Characteristics with the predicate comparison of Technological Characteristics with the predicate The subject device is safe and effective as the following predicate device. 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (K191355) by 3M Health Care. | Item(S) | Subject Device | Predicate Device | Comparison | |----------------|-------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------| | 510k# | K210147 | K191355 | | | Device
Name | Unico High
Performance
Surgical Mask
with Face
Shield | 3M™ High Fluid-
Resistant Surgical
Mask
ASTM Level 3 | 3M™ High Fluid-
Resistant
Procedure Mask | | Manufacturer | Unico Global, Inc. | 3M Health Care | | ## 9.1. Comparison Chart {5}------------------------------------------------ | ASTM Level | ASTM Level 3 | ASTM Level 3 | ASTM Level 3 | Same | | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------| | Indications
for use | The Unico High Performance
Surgical Mask and the Unico High
Performance Surgical Mask with
Face Shield are intended to be worn
to protect both the patient and
healthcare personnel from transfer
of microorganisms, body fluids,
and particulate material. These face
masks are intended for use in
infection control practices to reduce
potential exposure to blood and
body fluids. The face masks are
single use, disposable device,
provided non-sterile. | 3M™ High Fluid-
Resistant
Surgical Mask is
intended
to be worn to protect
both
the patient and
healthcare
personnel from
transfer of
microorganisms, body
fluids, and particulate
material. These face
masks
are intended for use in
infection control
practices
to reduce potential
exposure
to blood and body
fluids.
This is a single use,
disposable device,
provided
non-sterile. | 3M™ High Fluid-
Resistant Procedure
Mask is intended to
be worn to protect both
the patient and
healthcare personnel
from transfer of
microorganisms, body
fluids, and particulate
material.
These face masks are
intended for use in
infection control
practices to reduce
potential exposure to
blood and body fluids.
This is a single use,
disposable device,
provided non-sterile. | Same | | | | Materials | | | | | | Outer Cover | Polypropylene
Spunbond,
blue | Polypropylene
Spunbond,
green | Polypropylene
Spunbond,
green | Same | | | Insertion | Polypropylene
Spunbond,
White | Polypropylene
Spunbond,
White | Polypropylene
Spunbond,
White | Same | | | Filter | Polypropylene
Meltblown,
White | Polypropylene
Meltblown,
White | Polypropylene
Meltblown,
White | Same | | | Inner
Cover | Polypropylene
Spunbond,
White | Polypropylene
Thermal,
Bonded, White | Polypropylene
Thermal,
Bonded, White | Different | | | Nose Wire | PVC Coated
Zinc Wire | Polyethylene Coated
Steel Wire | Polyethylene Coated
Steel Wire | Different | | | Ear Loops | Cotton 50%
Spandex 50%
cord | Not Applicable | Spandex elastic cord
(polyurethane core with
polyethylene
terephthalate
/nylon cover ) | Different | | | Tie Strings | Polypropylene
Spunbond,
White | Polypropylene
Spunbond,
White or polyethylene
Terephthalate, white | N/A | Same | | | Anti-Glare
layer | Polypropylene
Spunbond,
Black | N/A | N/A | N/A | Different | | Face Shield | Protective film:
Polyethylene
100%
Film:
Polyethylene
terephthalate
100% | N/A | N/A | N/A | Different | | Design Features | | | | | | | Color | Blue (Outer) | | Green (Outer) | Green (Outer) | Different | | Style | Flat - Pleated | | Flat - Pleated | Flat - Pleated | Same | | Multiple
Layers | Yes | | Yes | Yes | Same | | Single Use | Yes | | Yes | Yes | Same | | Sterility | | | | | | | Sterile | Non-Sterile | | Non-Sterile | Non-Sterile | Same | | Dimensions | | | | | | | Length | 6.9" ± 0.2" | | 6.9" ± 0.2" | 6.9" ± 0.2" | Same | | Width | 3.74" ± 0.2" | | 3.5" ± 0.3" | 3.5" ± 0.3" | Different | | Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3 | | | | | | | Particulate
Filtration
Efficiency
(PFE) | Passed at ≥98% @ 0.1
micron
ASTM F2299 | | Passed at ≥98% @ 0.1
micron
ASTM F2299 | Passed at ≥98% @ 0.1
micron
ASTM F2299 | Same | | Fluid
Resistance | Passed at 160mm Hg
ASTM F1862 | | Passed at 160mm Hg
ASTM F1862 | Passed at 160mm Hg
ASTM F1862 | Same | | Bacterial
Filtration
Efficiency
(BFE) | Passed at ≥98%
ASTM F2101 | | Passed at ≥98%
ASTM F2101 | Passed at ≥98%
ASTM F2101 | Same | | Differential
Pressure | Passed at <6 mmH2O/cm²
MIL-M36954C | | Passed at <5
mmH2O/cm²
MIL-M36954C | Passed at <5
mmH2O/cm²
MIL-M36954C | Same | | Flammability | Passed ≥3 Seconds burn
time - Class 1
CFR 16 1610 | | Passed ≥3 Seconds
burn
time - Class 1
CFR 16 1610 | Passed ≥3 Seconds
burn
time - Class 1
CFR 16 1610 | Same | | Biocompatibility | | | | | | | Result | Non-cytotoxic, Non-
sensitizing, Non-irritating | | Non-cytotoxic, Non-
sensitizing, Non-
irritating | Non-cytotoxic, Non-
sensitizing, Non-
irritating | Same | {6}------------------------------------------------ {7}------------------------------------------------ #### 9.2. Discussion The subject device and the predicate device have indications for Use and has similar design and technological characteristics. The raw materials of some components are different, but the test results of the non-clinical performance tests and the biocompatibility tests support that the differences do not raise a concern in safety and effectiveness. The subject device also has additional features such as anti-glare layer and face shield, but there are to improve performance. The size of the subject device is little larger especially in width, but the difference is very minor. We have performed the biocompatibility and performance tests on the subject device and based on the test results we determine that the subject device is safe and effective as the predicate device despite these differences. #### 10. Performance Tests (Non-clinical) The following tests were performed on the subject device and the test results support that the subject device is safe and effective as the predicate device. | No | Test | Standard | Test method | Purpose | Acceptance criteria | Test results | |----|------------------------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------| | 1 | Particle
Filtration
Efficiency
Latex Particle
Challenge | ASTM
F2299 | Monodispersed
polystyrene latex
spheres (PSL)
were nebulized
(atomized), dried,
and passed
through the test
article | Performed to
evaluate the
non-viable
particle
filtration
efficiency
(PFE) of the
test article. | - | 98.3% | | 2 | Synthetic
Blood
Penetration
for Face
Masks
(sets of 32),
per set | ASTM
F1862 and
ISO 22609 | A test volume of
2 mL of synthetic
blood was
employed using
the targeting plate
method. | Procedure
was
performed to
evaluate
surgical
facemasks
and other
types of
protective. | 160mmHg | Not Seen | | 3 | Differential
Pressure
(Delta P) | EN
14683:2019,
Annex C and
ASTM
F2100-19. | On either side of
the test article
using a
manometer, at a
constant flow
rate. | The Delta P
test is
performed to
determine the
breathability
of test articles
by measuring
the
differential air
pressure. | <60 mm
H2O/cm² | 53 | | 4 | Flammability
Test, 16 CFR
part 1610 | 16 CFR Part
1610 | Article exhibits
flame spread and
it is less than 3.5
seconds or the test
articles exhibit an | This
procedure was
performed to
evaluate the
flammability | Class1: Burn
time ≥3.5
seconds

Class2: Not | Test Article
did not
ignite | | | | | average flame | of plain | applicable to | | | | | | spread less than | surface | plain surface | | | | | | 3.5 seconds. | clothing | textile fabrics | | | | | | | textiles by | | | | | | | | measuring the | Class 3: Burn | | | | | | | ease of | time <3.5 | | | | | | | ignition and | seconds | | | | | | | the speed of | | | | | | | | flame spread. | | | | 5 | Bacterial | ASTM | Employ a ratio of | BFE is a | ≥98 | 99% | | | Filtration | F2101-19 | The bacterial | measurement | | | | | Efficiency | and EN | challenge counts | of a respirator | | | | | | | | | | | | | (BFE) only | 14683:2019, | to sample effluent | material's | | | | | | Annex B. | counts, to | resistance to | | | | | | | determine percent | penetration of | | | | | | | bacterial filtration | bacteria. | | | | | | | efficiency | | | | | | | | (%BFE) | | | | | 6 | Cytotoxicity | ISO 10993-5 | The amount of | An extract of | Score: | 0 | | | | | test material | the test article | 0 ~ 4 | Pass | | | | | extracted was | was added to | | | | | | | based on | cell | | | | | | | ANSI/AAMI/ISO | monolayers | | | | | | | and USP surface | and incubated. | | | | | | | area or weight | The cell | | | | | | | recommendations. | monolayers | | | | | | | Test articles and | were | | | | | | | controls were | examined and | | | | | | | extracted in 1X | scored based | | | | | | | Minimal Essential | on the degree | | | | | | | Media with 5% | of cellular… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K210147](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K210147) **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