K Number

Device Name

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

Manufacturer

Unicoglobal, Inc.

Date Cleared

2021-12-22

(335 days)

Product Code

FXX

Regulation Number

878.4040

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K191355

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a surgical mask intended for protection from transfer of microorganisms, body fluids, and particulate material, not for treating a disease or condition.

Diagnostic

Explanation: This device is a surgical mask intended for protection from transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like layers of material, ear loops/tie strings, a nose piece, and an optional face shield, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The Unico High Performance Surgical Mask and Surgical Mask with Face Shield are physical barriers worn on the face. Their purpose is to prevent the transfer of microorganisms, body fluids, and particulate material between people. They do not analyze or test any biological samples.
Intended Use: The intended use clearly states their purpose is for protection and infection control by reducing exposure to blood and body fluids. This is a physical barrier function, not an in vitro diagnostic function.
Device Description: The description details the materials and construction of a mask and face shield, not components for analyzing biological samples.
Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration, penetration, pressure, flammability, biocompatibility), not on the accuracy or reliability of diagnostic test results.

Therefore, based on the provided information, the Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are not IVD devices. They are medical devices, specifically personal protective equipment (PPE).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FXX

Device Description

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.

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 personnel

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 is safe and effective as the predicate device.

1. Particle Filtration Efficiency Latex Particle Challenge

Standard: ASTM F2299
Test method: Monodispersed polystyrene latex spheres (PSL) were nebulized (atomized), dried, and passed through the test article
Purpose: Performed to evaluate the non-viable particle filtration efficiency (PFE) of the test article.
Acceptance criteria: -
Test results: 98.3%

2. Synthetic Blood Penetration for Face Masks (sets of 32), per set

Standard: ASTM F1862 and ISO 22609
Test method: A test volume of 2 mL of synthetic blood was employed using the targeting plate method.
Purpose: Procedure was performed to evaluate surgical facemasks and other types of protective.
Acceptance criteria: 160mmHg
Test results: Not Seen

3. Differential Pressure (Delta P)

Standard: EN 14683:2019, Annex C and ASTM F2100-19.
Test method: On either side of the test article using a manometer, at a constant flow rate.
Purpose: The Delta P test is performed to determine the breathability of test articles by measuring the differential air pressure.
Acceptance criteria:

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Summary

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.

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

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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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

· Classification Name: Surgical Mask (21 CFR 878.4040)
· Regulatory Class: II
Product Code: FXX

5. Device Description:

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.

8. Indications for Use

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
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

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