(335 days)
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.
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.
The provided text describes a 510(k) premarket notification for a surgical mask, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, and standalone performance, is not applicable.
However, I can extract the acceptance criteria and reported performance for the surgical mask based on the provided tables and text.
Acceptance Criteria and Device Performance for Unico High Performance Surgical Mask
| No. | Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | Particle Filtration Efficiency (PFE) | ASTM F2299 | ≥98% @ 0.1 micron (Implicit from comparison chart) | 98.3% |
| 2 | Synthetic Blood Penetration for Face Masks | ASTM F1862 and ISO 22609 | Passed at 160mmHg (Implicit from comparison chart) | Not Seen (meaning passed) |
| 3 | Differential Pressure (Delta P) | EN 14683:2019, Annex C and ASTM F2100-19 | <6.0 mmH2O/cm² (from "Acceptance criteria" column) | 5.3 |
| 4 | Flammability Test, 16 CFR part 1610 | 16 CFR Part 1610 | Class 1: Burn time ≥3.5 seconds | Test Article did not ignite (Passed) |
| 5 | Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 and EN 14683:2019, Annex B | ≥98% (Implicit from comparison chart) | 99% |
| 6 | Cytotoxicity | ISO 10993-5 | Score: 0 ~ 4 (meaning non-cytotoxic) | 0, Pass (Non-cytotoxic) |
| 7 | Sensitization | ISO 10993-10 | No allergic or hypersensitivity reaction | No significantly greater biological reaction than control article (Non-sensitizing) |
| 8 | Irritation | ISO 10993-10 | No potential irritant effect | No significantly greater biological reaction than control article (Non-irritating) |
Since this is a submission for a surgical mask and not an AI/ML medical device, the following points are not applicable (N/A):
- Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (Not an AI/ML device)
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (Not an AI/ML device)
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device)
- The sample size for the training set: N/A (Not an AI/ML device)
- How the ground truth for the training set was established: N/A (Not an AI/ML device)
The study proving the device meets the acceptance criteria consists of a series of performance and biocompatibility tests conducted on the Unico High Performance Surgical Mask based on relevant ASTM, ISO, EN, and CFR standards. These tests demonstrate the mask's barrier properties (PFE, BFE, Fluid Resistance), breathability (Differential Pressure), flammability, and biocompatibility (Cytotoxicity, Sensitization, Irritation). The results, as shown in the table above, meet or exceed the specified acceptance criteria for an ASTM Level 3 surgical mask.
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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.
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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 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
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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
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- · 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 | |
| DeviceName | Unico HighPerformanceSurgical Maskwith FaceShield | 3M™ High Fluid-Resistant SurgicalMaskASTM Level 3 | 3M™ High Fluid-ResistantProcedure Mask |
| Manufacturer | Unico Global, Inc. | 3M Health Care |
9.1. Comparison Chart
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| ASTM Level | ASTM Level 3 | ASTM Level 3 | ASTM Level 3 | Same | |
|---|---|---|---|---|---|
| Indicationsfor use | The Unico High PerformanceSurgical Mask and the Unico HighPerformance Surgical Mask withFace Shield are intended to be wornto protect both the patient andhealthcare personnel from transferof microorganisms, body fluids,and particulate material. These facemasks are intended for use ininfection control practices to reducepotential exposure to blood andbody fluids. The face masks aresingle use, disposable device,provided non-sterile. | 3M™ High Fluid-ResistantSurgical Mask isintendedto be worn to protectboththe patient andhealthcarepersonnel fromtransfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasksare intended for use ininfection controlpracticesto reduce potentialexposureto blood and bodyfluids.This is a single use,disposable device,providednon-sterile. | 3M™ High Fluid-Resistant ProcedureMask is intended tobe worn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial.These face masks areintended for use ininfection controlpractices to reducepotential exposure toblood and body fluids.This is a single use,disposable device,provided non-sterile. | Same | |
| Materials | |||||
| Outer Cover | PolypropyleneSpunbond,blue | PolypropyleneSpunbond,green | PolypropyleneSpunbond,green | Same | |
| Insertion | PolypropyleneSpunbond,White | PolypropyleneSpunbond,White | PolypropyleneSpunbond,White | Same | |
| Filter | PolypropyleneMeltblown,White | PolypropyleneMeltblown,White | PolypropyleneMeltblown,White | Same | |
| InnerCover | PolypropyleneSpunbond,White | PolypropyleneThermal,Bonded, White | PolypropyleneThermal,Bonded, White | Different | |
| Nose Wire | PVC CoatedZinc Wire | Polyethylene CoatedSteel Wire | Polyethylene CoatedSteel Wire | Different | |
| Ear Loops | Cotton 50%Spandex 50%cord | Not Applicable | Spandex elastic cord(polyurethane core withpolyethyleneterephthalate/nylon cover ) | Different | |
| Tie Strings | PolypropyleneSpunbond,White | PolypropyleneSpunbond,White or polyethyleneTerephthalate, white | N/A | Same | |
| Anti-Glarelayer | PolypropyleneSpunbond,Black | N/A | N/A | N/A | Different |
| Face Shield | Protective film:Polyethylene100%Film:Polyethyleneterephthalate100% | 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 | |
| MultipleLayers | 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 | |||||
| ParticulateFiltrationEfficiency(PFE) | Passed at ≥98% @ 0.1micronASTM F2299 | Passed at ≥98% @ 0.1micronASTM F2299 | Passed at ≥98% @ 0.1micronASTM F2299 | Same | |
| FluidResistance | Passed at 160mm HgASTM F1862 | Passed at 160mm HgASTM F1862 | Passed at 160mm HgASTM F1862 | Same | |
| BacterialFiltrationEfficiency(BFE) | Passed at ≥98%ASTM F2101 | Passed at ≥98%ASTM F2101 | Passed at ≥98%ASTM F2101 | Same | |
| DifferentialPressure | Passed at <6 mmH2O/cm²MIL-M36954C | Passed at <5mmH2O/cm²MIL-M36954C | Passed at <5mmH2O/cm²MIL-M36954C | Same | |
| Flammability | Passed ≥3 Seconds burntime - Class 1CFR 16 1610 | Passed ≥3 Secondsburntime - Class 1CFR 16 1610 | Passed ≥3 Secondsburntime - Class 1CFR 16 1610 | Same | |
| Biocompatibility | |||||
| Result | Non-cytotoxic, Non-sensitizing, Non-irritating | Non-cytotoxic, Non-sensitizing, Non-irritating | Non-cytotoxic, Non-sensitizing, Non-irritating | Same |
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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 | ParticleFiltrationEfficiencyLatex ParticleChallenge | ASTMF2299 | Monodispersedpolystyrene latexspheres (PSL)were nebulized(atomized), dried,and passedthrough the testarticle | Performed toevaluate thenon-viableparticlefiltrationefficiency(PFE) of thetest article. | - | 98.3% |
| 2 | SyntheticBloodPenetrationfor FaceMasks(sets of 32),per set | ASTMF1862 andISO 22609 | A test volume of2 mL of syntheticblood wasemployed usingthe targeting platemethod. | Procedurewasperformed toevaluatesurgicalfacemasksand othertypes ofprotective. | 160mmHg | Not Seen |
| 3 | DifferentialPressure(Delta P) | EN14683:2019,Annex C andASTMF2100-19. | On either side ofthe test articleusing amanometer, at aconstant flowrate. | The Delta Ptest isperformed todetermine thebreathabilityof test articlesby measuringthedifferential airpressure. | <60 mmH2O/cm² | 53 |
| 4 | FlammabilityTest, 16 CFRpart 1610 | 16 CFR Part1610 | Article exhibitsflame spread andit is less than 3.5seconds or the testarticles exhibit an | Thisprocedure wasperformed toevaluate theflammability | Class1: Burntime ≥3.5secondsClass2: Not | Test Articledid notignite |
| 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 | |||||
| bovine serum for | destruction. | |||||
| 24-25 hours at 37 | ||||||
| ± 1°C with | ||||||
| agitation. | ||||||
| 7 | Sensitization | ISO 10993- | The USP 0.9% | Determine the | No allergic or | The test |
| 10 | Sodium Chloride | potential | hypersensitivity | article sites | ||
| for Injection | allergenic or | reaction | did not | |||
| (NaCl) and | sensitizing | show a | ||||
| Cottonseed Oil | capacity of | significantly | ||||
| (CSO) extracts of | the test | greater | ||||
| the test article, | article. The | biological | ||||
| Surgical Mask, | study was | reaction | ||||
| elicited no | used as a | than the | ||||
| reaction at the | procedure for | sites | ||||
| challenge (0% | screening of | injected | ||||
| sensitization), | contact | with the | ||||
| following an | allergens in | control | ||||
| induction phase. | guinea pigs | article. | ||||
| 8 | Irritation | ISO 10993- | The USP 0.9% | Determine the | No potential | The test |
| 10 | Sodium Chloride | potential | irritant effect | article sites | ||
| for Injection | irritation | did not | ||||
| (NaCl) and | effects of the | show a | ||||
| Cottonseed Oil | test article | significantly | ||||
| (CSO) extracts of | extract as a | greater | ||||
| the test article, | result of an | biological |
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K210147 – Page 6 of 7
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| Surgical Mask,were evaluatedfor their potentialto produceirritation afterintracutaneousinjection in NewZealand Whiterabbits. | intracutaneousinjection inNew ZealandWhite rabbits. | reactionthan thesitesinjectedwith thecontrolarticle. | ||||
|---|---|---|---|---|---|---|
| -- | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------- | ------------------------------------------------------------------------------ | -- | -- |
11. Conclusions:
Based on the information provided in this premarket notification, Unicoglobal, Inc. concludes that the Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are as safe, effective, and perform to the predicate device as described herein in.
§ 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.