Procedure mask/Surgical mask/Face mask

K220194 · Winner Medical Co., Ltd. · FXX · May 17, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220194
• Device Name: Procedure mask/Surgical mask/Face mask
• Applicant: Winner Medical Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: May 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Procedure mask/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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

Device Story

Three-layer, flat-pleated, single-use surgical face mask; inner/outer layers polypropylene nonwoven; middle layer polypropylene melt-blown nonwoven. Available in ear-loop (polyester/spandex) or tie-on (polypropylene) configurations. Includes iron/polypropylene nose clip for fit adjustment. Used in clinical settings by healthcare personnel and patients to reduce exposure to blood, body fluids, and particulates. Device provides physical barrier; performance validated against ASTM F2100-19 standards for fluid resistance, particulate filtration, and bacterial filtration. Non-sterile, disposable.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F1862 (synthetic blood penetration), ASTM F2299 (PFE), ASTM F2101 (BFE), EN 14683 (differential pressure), 16 CFR 1610 (flammability), and ISO 10993-5/10 (cytotoxicity, sensitization, irritation). All results met ASTM F2100-19 Level 1 and Level 2 acceptance criteria.

Technological Characteristics

Three-layer polypropylene nonwoven construction. Sensing/actuation: None (passive barrier). Dimensions: 17.5x9.5 cm or 14.5x9 cm. Connectivity: None. Sterilization: Non-sterile. Standards: ASTM F2100-19, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material in infection control practices. Single-use, disposable, non-sterile.

Regulatory Classification

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

• Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask (K211462)

Submission Summary (Full Text)

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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 and 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.

May 17, 2022

Winner Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K220194

Trade/Device Name: Procedure mask/Surgical mask/Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 9, 2022 Received: April 20, 2022

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K220194

Device Name

Procedure mask/Surgical mask/Face mask

## Indications for Use (Describe)

The Procedure mask/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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

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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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section

807.92. The assigned 510(k) Number: K220194

- 1. Date of Preparation: 01/18/2022
- 2. Sponsor Identification

## Winner Medical Co., Ltd.

Winner Industrial Park, No.660 Bulong Road, Longhua District, Shenzhen Guangdong, China 518109

Establishment Registration Number: 9616433

Contact Person: Mingni Liu Position: Regulatory Affairs Tel: [phone]-8822 Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)

## Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Procedure mask/Surgical mask/Face mask Common Name: Surgical Face Mask

Regulatory Information Classification Name: Mask, Surgical; Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040; Review Panel: General Hospital;

### Indications for use:

The Procedure mask/Surgical mask/Face 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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

### Device Description:

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile. All specifications of the proposed device are provided in table 1.

| Product name | ASTM F2100-19<br>level | Ear strap type | Size (cm) | Color | Layers | Sterilization |
|-------------------------------------------------|------------------------|----------------|-----------|-------|--------|---------------|
| Procedure<br>mask/Surgical<br>mask/Face<br>mask | Level 1 | Ear loop | 17.5x9.5 | Blue | 3 | Non-sterile |
| | | | 17.5x9.5 | Black | | |
| | | Ear loop | 14.5x9 | Blue | | |
| | | | 14.5x9 | Black | | |
| | | Tie-on | 17.5x9.5 | Blue | | |

| Table 1 Procedure mask/Surgical mask Description | | |
|--------------------------------------------------|--|--|
| | | |

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| | Level 2 | Ear loop | 17.5x9.5 | Blue | |
|--|---------|----------|----------|-------|--|
| | | | | Black | |
| | | | 14.5x9 | Blue | |
| | | | | Black | |
| | | Tie-on | 17.5x9.5 | Blue | |

#### న్. Identification of Predicate Device

510(k) Number: K211462 Product Name: Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask (Select Level 1 and Level 2 masks as predicate device)

#### Summary of Non-Clinical Test 6.

Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > ASTM F1862/F1862M: 2017 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
- > ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
- > ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
- > ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- > EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
- > 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- > ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization

| Test Methodology | Purpose | Acceptance Criteria | Result |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resistance to<br>Penetration by<br>Synthetic blood | The test was performed in accordance with ASTM<br>F1862/F1862M: 2017<br>Standard Test Method for<br>Resistance of Medical Face | Level 1: No penetration<br>at 80 mmHg | Level 1: Pass at<br>80mmHg |
| | | Level 2: No penetration<br>at 120 mmHg | Level 2: Pass at<br>120mmHg |
| | Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume at<br>a Known Velocity) to evaluate<br>the effectiveness of the test<br>article from possible exposure<br>to blood and other body fluids. | | |
| | The test was performed in<br>accordance with ASTM<br>F2299/F2299M-03 (2017)<br>Standard Test Method for<br>Determining the Initial<br>Efficiency of Material Used in<br>medical Face Masks to<br>Penetration by Particulates<br>using Latex Spheres to<br>determine the particle<br>filtration efficiency (PFE) of<br>the test article. | Level 1: ≥95% | Blue mask:<br>Pass at 96.05%<br>Black mask:<br>Pass at 96.03% |
| Particulate<br>Filtration Efficiency | | Level 2: ≥98% | Blue mask:<br>Pass at 98.78%<br>Black mask:<br>Pass at 98.75% |
| Bacterial Filtration<br>Efficiency | The test was performed in<br>accordance with ASTM<br>F2101: 2019 Standard Test<br>Method for Evaluating the<br>Bacterial Filtration Efficiency<br>(BFE) of Medical Face Mask<br>Materials, Using a Biological<br>Aerosol of Staphylococcus<br>aureus to determine the<br>bacterial filtration efficiency<br>(BFE) of the test article. | Level 1: ≥95% | Blue mask:<br>Pass at 98.25%<br>Black mask:<br>Pass at 98.25% |
| | | Level 2: ≥98% | Blue mask:<br>Pass at 98.72%<br>Black mask:<br>Pass at 98.73% |
| Differential<br>Pressure | The test was performed in<br>accordance with EN<br>14683:2019+AC: 2019 Annex<br>C Medical face masks -<br>Requirements and test<br>methods to determine the<br>differential pressure of the test<br>article. | Level 1:<br><5.0 mmH2O/cm² | Blue mask:<br>Pass at 3.5 mmH2O/cm²<br>Black mask:<br>Pass at 3.5 mmH2O/cm² |
| | | Level 2:<br><6.0 mmH2O/cm² | Blue mask:<br>Pass at 3.5 mmH2O/cm² |
| | | | |
| | | | Black mask:<br>Pass at 3.6 mmH2O/cm2 |
| Flammability | The test was performed in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles to evaluate the flammability of the test article. | Class 1 | Class 1 |
| Cytotoxicity | The test was performed in accordance with ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity to evaluate the cytotoxicity of the test article. | The viability should be ≥70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | The viability was ≥70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract.<br>Under the conditions of the study, the proposed device was non-cytotoxic. |
| Sensitization | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization to evaluate the sensitization of the test article. | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization to evaluate the irritation of the test article. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |

Table 2 Comparison of Procedure mask/Surgical mask

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#### 7. Clinical Test Conclusion

No clinical study is included in this submission.

#### 8. Technological Characteristics Comparison

| ITEM | Proposed Device | Predicate Device<br>K211462 | Remark | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------|
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| Indications<br>for<br>Use | The Procedure mask/Surgical<br>mask is intended to be worn to<br>protect both the patient and<br>healthcare personnel from transfer<br>of microorganisms, body fluids,<br>and particulate material. These<br>face masks are intended for use in<br>infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a<br>single-use, disposable device,<br>provided non-sterile. | The Disposable Ear-loop Medical Face<br>Mask/Disposable Tie-On Medical Face<br>Mask is intended to be worn to protect<br>both the patient and healthcare personnel<br>from transfer of microorganisms, body<br>fluids, and particulate material. These<br>face masks are intended for use in<br>infection control practices to reduce the<br>potential exposure to blood and body<br>fluids. This is a single-use, disposable<br>device, provided nonsterile. | Same | |
| Mask style | Flat pleated | Flat pleated | Same | |
| Design feature | Ear loop / Tie-on | Ear loop / Tie-on | Same | |
| Dimension | Ear loops:<br>Body: 175 mm×95 mm, nose clip:<br>110mm, Ear-loop: 178mm<br>Body: 145 mm×90 mm, nose clip:<br>85mm, Ear-loop: 145mm<br>Tie-on:<br>Body: 175 mm×95 mm, nose clip:<br>110mm, Ear-loop: 900mm | Ear loops: Body: 175 mm×95 mm, nose<br>clip: 125mm, Ear-loop: 175mm<br>Tie-on: Body: 175 mm×95 mm, nose<br>clip: 125mm, Tie strings: 910mm | Different | |
| ASTM<br>F2100<br>Level | Level 1 | Level 1 | Level 2 | Same |
| Fluid<br>Resistance | Pass<br>at<br>80mmHg | Pass at 80mmHg | Pass<br>at<br>120<br>mmHg | Same |

## Table 3 Comparison of Procedure mask/Surgical mask

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| Particulate<br>filtration<br>efficiency | | Blue mask:<br>Pass at 96.05% | Blue mask:<br>Pass at 98.78% | Pass at 98.2% | | Pass at 99.3% | Different |
|-----------------------------------------|--------------------|-----------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------|--------------------------------|-----------|
| | | Black mask:<br>Pass at 96.03% | Black mask:<br>Pass at 98.75% | | | | |
| Bacterial<br>filtration<br>efficiency | | Blue mask:<br>Pass at 98.25% | Blue mask:<br>Pass at 98.72% | Pass at 98.9% | | Pass at 99.4% | Different |
| | | Black mask:<br>Pass at 98.25% | Black mask:<br>Pass at 98.73% | | | | |
| Differential<br>pressure | | Blue mask:<br>Pass at 3.5 mmH2O/cm² | Blue mask:<br>Pass at 3.5 mmH2O/cm² | Passed at 3.6mmH2O/cm² | | Pass at 4.0mmH2O/cm2 | Different |
| | | Black mask:<br>Pass at 3.5 mmH2O/cm² | Black mask:<br>Pass at 3.6 mmH2O/cm² | | | | |
| | | | | | | | |
| Flammability | | Class 1 | | Class 1 | | | Same |
| Label/Labeling | | Complied with 21 CFR part 801 | | Complied with 21 CFR part 801 | | | Same |
| Materials | | | | | | | |
| Ear loop | | Polyester and spandex | | Nylon and Spandex | | | |
| Tie strings | | 38 /m² polypropylene nonwoven | | 35g/ m² PP non-woven cloth | | | |
| Nose clip | | Iron and polypropylene | | Aluminum wire | | | |
| Mask<br>body | Outer<br>material | 25g/m²<br>polypropylene<br>nonwoven | 30g/m²<br>polypropylene<br>nonwoven | 23g/ m² PP non-woven cloth | | | Different |
| | Middle<br>material | 25g/m²<br>polypropylene<br>melt-blown<br>nonwoven | 30g/m²<br>polypropylene<br>melt-blown<br>nonwoven | 22g/ m² PP<br>non-woven<br>cloth | 25g/m² PP<br>non-woven<br>cloth | 33g/m²PP<br>non-woven<br>cloth | |
| | Inner<br>material | 25g/m²<br>polypropylene<br>nonwoven | 30g/m²<br>polypropylene<br>nonwoven | 20g/ m² PP non-woven cloth | | | |
| Colors | | Blue; Black | | Blue | | | Different |
| Biocompatibility | | | | | | | |
| Cytotoxicity | | Under the conditions of the study, the proposed device was non-cytotoxic. | | Under the conditions of the study, the proposed device was non-cytotoxic. | | | Same |
| Sensitization | | Under the conditions of the study, the proposed device was non-sensitizing. | | Under the conditions of the study, the proposed device was non-sensitizing. | | | Same |
| Irritation | | Under the conditions of the study, the proposed device was non-irritating. | | Under the conditions of the study, the proposed device was non-irritating. | | | Same |

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### 510(k) Summary

| | non-irritating. | | |
|---------------|-----------------|-------------|------|
| Sterilization | | | |
| Method | Non-sterile | Non-sterile | Same |

## Different - Dimension (mm)

The dimension for the proposed device is different from the predicate device. The mask body of the proposed device is provided in two dimensions: ear loop masks - 17.5×9.5 cm and 14.5×9 cm; tie-on mask - 17.5×9.5 cm. While the predicate device is only provided in one dimension, 17.5×9.5 cm. However, the difference in dimension of mask body does not affect indications for use and will not raise any safety issues. The dimensions of the nose clip, ear loop and ties for the proposed device are different from the predicate device. However, these difference does not affect the protective performance of masks. The nose clip is just to fix the mask on the bridge of the nose and keep it from falling off. And the ear loop and ties are also designed to attach masks to the user's mouth and nose. Thus, this difference will not affect the safety and effectiveness of the proposed device.

## Different - Particulate efficiency

The test result for particulate filtration efficiency for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 1 / level 2 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of proposed device.

### Different - Bacterial filtration efficiency

The test result for bacterial filtration efficiency for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 1 / level 2 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of proposed device.

## Different - Differential pressure

The test result for differential pressure for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 1 / level 2 mask based on ASTM F2100-19. Thus, this difference will not affectiveness of proposed device.

### Different - Materials

The material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the proposed device.

## Different - Colors

The color of proposed device is provided in blue and black, while the predicate device is blue. However,

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the biocompatibility test has been conducted and test results did not show any adverse effects. Thus, this difference will not affect the safety and effectiveness of the proposed device.

- Conclusion 9.
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K211462.