CPL Surgical Face Mask

K213136 · Control Print Limited · FXX · Dec 24, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K213136
• Device Name: CPL Surgical Face Mask
• Applicant: Control Print Limited
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.

Device Story

3-ply flat-pleated surgical face mask; inner/outer layers spun-bond polypropylene; middle layer melt-blown polypropylene filter; polypropylene-coated galvanized nose wire; available as ear-loop (braided elastic) or tie-on (non-woven string) models. Used in clinical settings by healthcare personnel and patients to reduce exposure to blood, body fluids, and airborne particles. Disposable, single-use, non-sterile. Provides physical barrier protection; performance verified against ASTM F2100 Level 3 standards.

Clinical Evidence

No clinical data. Bench testing only. Performance verified per ASTM F2100-19, ASTM F2101-19 (BFE ≥98%), ASTM F2299 (PFE ≥98%), ASTM F1862 (fluid resistance at 160 mmHg), and 16 CFR 1610 (flammability Class 1). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10 (non-cytotoxic, non-irritating, non-sensitizing).

Technological Characteristics

3-ply flat-pleated construction. Materials: spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter), polypropylene-coated galvanized wire (nose wire). Dimensions: 175x95 mm. Performance: ASTM F2100 Level 3. Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10. Non-sterile, single-use.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material; intended for infection control practices to reduce potential exposure to blood and body fluids.

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 Surgical Face Mask (K203801)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 24, 2021

Control Print Limited % Manoj Zacharias US Agent Liberty Management Group Ltd. 75 Executive Drive, Suite 114 Aurora, Illinois 60504

Re: K213136

Trade/Device Name: CPL Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: September 20, 2021 Received: September 27, 2021

Dear Manoj Zacharias:

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

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542 of the Act); 21 CFR 1000-1050.

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-

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,

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) K213136

Device Name CPL Surgical Face Mask

## Indications for Use (Describe)

The surgical face mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only,

Available models: Surgical Face Mask EL (Ear loops) Surgical Face Mask TO (Tie-on)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Control Print. The words "CONTROL" and "PRINT" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a graphic of four red circles of varying sizes, arranged in a diagonal line. The largest circle is at the top, and the smallest circle is at the bottom.

# 510(k) Summary (K213136)

[AS REQUIRED BY 21CFR807.92]

## APPLICANT INFORMATION I.

| Submitter's Name | Control Print Limited |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | Village Bhatian, Near TVS Factory, Bharatgarh Road,<br>Nalagarh, District Solan -174101,<br>Himachal Pradesh, India |
| Name of Contact Person | Mr. Pankaj Sharma |
| Designation | Manager Quality Assurance |
| Division Name of Contact Person | Quality Management |
| Contact Number | 91 9805020592 |
| Contact E-mail | [e-mail] |
| Date of Summary Prepared | 22 December 2021 |

## II. DEVICE DETAILS

| Device Trade Name | CPL Surgical Face Mask |
|----------------------------|----------------------------------------------|
| Device Common Name | Surgical Face Mask |
| Model(s) | Surgical Face Mask EL, Surgical Face Mask TO |
| Device Classification name | Mask, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |

# Page 1 of 8

Control Print Limited, Village Bhalian, Near TVS Factory, Bharatgarh 174101, Dist. Solan, Himachal Pradesh, India t. [phone] / 9805020580 / 81 / 82 | e. [e-mail] | w. www.controlprint.com CIN. L22219MH1991PLC059800

MUMBAI (Regd.Office) · AHMEDABAD · CHANDIGARH · CHENNAI · COLOMBO · DELHI · GUWAHATI HYDERABAD · JAMSHEDPUR · KERALA · KOLKATA · NEPAL · PUNE

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Image /page/4/Picture/0 description: The image shows the logo for Control Print. The logo is composed of the words "CONTROL" and "PRINT" stacked on top of each other in a bold, sans-serif font. To the right of the text is a series of four red circles arranged in a diagonal line. The circles appear to be of slightly different sizes, with the largest circle in the middle.

## PREDICATE DEVICE DETAILS III.

| Device Trade Name | Disposable Surgical Face Mask |
|--------------------------|---------------------------------------------|
| Device Manufacturer Name | Anhui Jiabao Protective Equipments Co., Ltd |
| Model(s) | JB-DMO3 (Ear Loops), JB-DMO4 (Tie on) |
| 510(k) Number | K203801 |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |

## DEVICE DESCRIPTION IV.

The CPL Surgical Face Mask is a 3-ply flat-pleated mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core galvanized wire.

The model Surgical Face Mask EL is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of braided elastic band. The model Surgical Face Mask TO is provided with non-woven tie-on string.

The dimensions of the test item are: length- 175 ± 5 mm and width- 95 ± 5 mm. The ear loop length of the model Surgical Face Mask EL is 170± 5 mm. The tie-on of the model Surgical Face Mask TO has a top strap length of 410 ± 10 mm and bottom strap length of 385 ± 10 mm.

The surgical masks are single-use, disposable devices, provided non-sterile.

### V. INTENDED USE

When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.

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Image /page/5/Picture/0 description: The image contains the logo for Control Print. The words "CONTROL" and "PRINT" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a graphic of four red circles in a curved line, with the top circle being the largest and the bottom circle being the smallest. The logo is simple and modern, and the red circles add a pop of color.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

# Table 1: General Comparison

| SI.<br>No | Features<br>compared | Proposed Device | Predicate Device | Result | | | |
|----------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|------------|--|
| | General Information | | | | | | |
| 1. | 510(k) Number | K213136 | K203801 | - | | | |
| 2. | Manufacturer | Control Print Limited | Anhui Jiabao Protective<br>Equipments Co., Ltd | - | | | |
| 3. | Common Name | Surgical face mask | Surgical face mask | Same | | | |
| 4. | Classification Name | Mask, Surgical | Mask, Surgical | Same | | | |
| 5. | Classification and<br>Regulation number | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Same | | | |
| 6. | Product Code | FXX | FXX | Same | | | |
| 7. | Indications For Use | The surgical face mask are<br>intended to be worn to protect<br>both the patient and healthcare<br>personnel<br>from transfer<br>of<br>microorganisms, body fluids and<br>particulate material. The face<br>masks are intended for use in<br>infection control practices to<br>reduce the potential exposure to<br>blood & body fluid. This device<br>is disposable, non-sterile and for<br>single use only.<br>Available models:<br>Surgical Face Mask EL (Ear<br>loops)<br>Surgical Face Mask TO (Tie-<br>on) | The Disposable Surgical Face<br>Mask is intended to be worn to<br>protect both the patient and<br>healthcare<br>personnel<br>from<br>of<br>transfer<br>microorganisms,<br>body<br>fluids<br>and particulate<br>material. These face masks are<br>intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and<br>body fluids. This a single use,<br>disposable device(s), provided<br>non-sterile. | Same | | | |
| SI.<br>No | Features<br>compared | Proposed Device | Predicate Device | Result | | | |
| 8. | Model specifications | Surgical Face Mask EL(3 ply flatpleated masks with ear loops)<br>Surgical Face Mask TO (3 ply<br>flat-pleated masks with tie-on) | JB-DM03(Ear Loops, Flat<br>Pleated, 3 layers)<br>JB-DM04(Tie-On, Flat Pleated,<br>3 layers) | Same | | | |
| | Materials | | | | | | |
| 9. | Outer layer | Spun bond polypropylene | Spun bond polypropylene | Same | | | |
| 10. | Filter layer | Melt blown polypropylene | Melt blown polypropylene filter | Same | | | |
| 11. | Inner layer | Spun bond polypropylene | Spun bond polypropylene | Same | | | |
| 12. | Nose wire | Polypropylene coated single<br>core galvanized wire | PE and iron | Different¹ | | | |
| 13. | Ear loop/ Tie-on | For model: Surgical Face<br>Mask EL<br>Ear Loop: Braided Elastic Band<br>For model: Surgical Face<br>Mask TO<br>Tie-on: Non-woven tie-on<br>string | For model: JB-DM03<br>Ear Loop: Nylon and spandex<br>For model: JB-DM04<br>Tie-on: Spun-bond<br>polypropylene | Different² | | | |
| 14. | Mask color | Blue | Blue | Same | | | |
| 15. | Dimensions | Length- 175 ± 5 mm<br>Width- 95 ± 5 mm<br>For model: Surgical Face<br>Mask EL<br>Ear Loop Length: 170± 5 mm<br>For model: Surgical Face<br>Mask TO<br>Tie-on strap length<br>- Top: 410 ± 10 mm<br>Bottom : 385 ± 10 mm | Length- 175 ± 5 mm<br>Width- 95 ± 5 mm | Same | | | |
| SI.<br>No | Features<br>compared | Proposed Device | Predicate Device | Result | | | |
| 16. | OTC Use | Yes | Yes | Same | | | |
| 17. | Sterility | Non-sterile | Non-sterile | Same | | | |
| 18 | Reusability | Single use | Single use | Same | | | |
| 19 | ASTM F2100 Level | Level 3 | Level 2 & 3 | Similar | | | |
| Non Clinical Testing | | | | | | | |
| Tests Performed | | Model No .:<br>Surgical<br>Face Mask<br>EL | Model No.:<br>Surgical<br>Face Mask<br>TO | Model No .:<br>JB-DM03<br>(Ear loop<br>model) | Model No.:<br>JB-DM04<br>(Tie-on<br>model) | Result | |
| 20. | Fluid resistance | Pass at 160<br>mmHg | Pass at 160<br>mmHg | Pass at 120<br>mmHg | Pass at 160<br>mmHg | Different3 | |
| 21. | Flammability | Class 1 | Class 1 | Class 1 | Class 1 | Same | |
| 22. | Particulate Filtration<br>Efficiency (PFE) | ≥ 98% | ≥ 98% | ≥ 98% | ≥ 98% | Same | |
| 23. | Bacterial Filtration<br>Efficiency (BFE) | ≥ 98% | ≥ 98% | ≥ 98% | ≥ 98% | Same | |
| 24. | Differential pressure<br>(ΔΡ) | < 6.0 mm<br>H2O/cm² | < 6.0 mm<br>H2O/cm² | < 6.0 mm<br>H2O/cm² | < 6.0 mm<br>H2O/cm² | Same | |
| 25. | Biocompatibility<br>Testing | No potential<br>cytotoxicity<br>Non-irritating<br>Non-<br>sensitizing | No potential<br>cytotoxicity<br>Non-irritating<br>Non-<br>sensitizing | No potential<br>cytotoxicity<br>Non-irritating<br>Non-sensitizing | No potential<br>cytotoxicity<br>Non-irritating<br>Non-sensitizing | Same | |

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Image /page/6/Picture/0 description: The image shows the logo for Control Print. The words "CONTROL PRINT" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a series of red circles that are arranged in a vertical line. The circles appear to be getting smaller as they go down.

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Image /page/7/Picture/0 description: The image shows the logo for Control Print. The words "CONTROL" and "PRINT" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a graphic of four red circles of varying sizes, arranged in a diagonal line. The logo is simple and modern, and the red circles add a pop of color.

# VII. JUSTIFICATION FOR DIFFERENCES

The difference is mainly observed in the nose strip, ear loop/tie-on and ASTM F2100 level of ear loop model. The differences between proposed device and the predicate device are discussed in detail below and the justifications are included:

Different(1): The proposed device is using nose wire of polypropylene coated single core galvanized wire whereas the predicate device is using nose wire made of PE and iron.

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Image /page/8/Picture/0 description: The image contains the logo for Control Print. The logo has the words "CONTROL" and "PRINT" stacked on top of each other in a bold, sans-serif font. To the right of the words are five red circles arranged in a curved line, resembling a stylized arrow or motion graphic. The overall design is simple and modern, with a clear emphasis on the company name.

Different(2): In the proposed device, for model Surgical Face Mask EL, ear loop is made of braided elastic band. But, in the predicate device, for model JB-DM03, the ear loop is made of nylon and spandex. The proposed device model Surgical Face Mask TO is provided with non-woven tie-on string whereas in the predicate device model JB-DM04 the tie-on is made of spun-bond polypropylene.

Different(3): The proposed device model Surgical Face Mask EL has passed the acceptance criteria for level 3 whereas the predicate device model JB-DM03 has passed the acceptance criteria for level 2 as per ASTM F2100.

### VIII. PERFORMANCE DATA

#### A. Non- Clinical Data

# Performance Tests

CPL Surgical Face Mask is subjected to the following performance tests according to the requirements provided in the guidance Surgical Masks - Premarket Notification [510(k)] Submissions :

- . Fluid resistance
- . Bacterial filtration efficiency
- . Particulate filtration efficiency
- . Differential pressure
- . Flammability

The performance testing of the proposed device was conducted using 3 nonconsecutive lots to demonstrate that it meet the acceptance criteria and specification in the method shown below:

ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks

ASTM F2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.

ASTM F2299 / F2299M - 03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

EN 14683 (Annex C): 2019 Medical Face Masks - Requirements And Test Methods

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Image /page/9/Picture/0 description: The image contains the logo for Control Print. The words "CONTROL" and "PRINT" are stacked on top of each other in a bold, sans-serif font. To the right of the text, there is a cluster of red circles of varying sizes, arranged in a cascading pattern. The circles appear to be a design element associated with the Control Print brand.

ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

16 CFR 1610 Standard for the Flammability of clothing textiles

| Table 2: Performance Testing Summary | | | |
|--------------------------------------|--|--|--|
|--------------------------------------|--|--|--|

| Sl.<br>No | Test Performed | Proposed Device | | Acceptance<br>criteria for Level<br>3 Classification<br>as per ASTM<br>F2100<br>Requirements | Result |
|-----------|---------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------|--------|
| | | Model No. :<br>Surgical Face<br>Mask EL | Model No. :<br>Surgical Face<br>Mask TO | | |
| 1. | Fluid resistance<br>ASTM F1862/<br>F1862M-17 | Pass at 160<br>mmHg | Pass at 160<br>mmHg | Pass at 160<br>mmHg | Pass |
| 2. | Particulate Filtration<br>Efficiency (PFE)<br>ASTM F2299 / F2299M<br>- 03(2017) | >98% | >98% | ≥ 98% | Pass |
| 3. | Bacterial Filtration<br>Efficiency (BFE)<br>ASTM F2101-19 | > 98% | > 98% | ≥ 98% | Pass |
| 4. | Differential pressure<br>(ΔΡ)<br>EN 14683 (Annex C):<br>2019 | < 4.0 mm<br>H2O/cm² | < 5.0 mm<br>H2O/cm² | < 6.0 mm H2O/cm² | Pass |
| 5. | Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | Pass |

# Biocompatibility

The materials used in the CPL Surgical Face Mask are biocompatible based on the biocompatibility tests mentioned in the guidance Surgical Masks - Premarket Notification [510(k)] Submissions:

- . In-vitro Cytotoxicity
- . Skin irritation
- Skin Sensitization .

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Image /page/10/Picture/0 description: The image shows the logo for Control Print. The words "CONTROL PRINT" are stacked on top of each other in bold, black font. To the right of the words are four red circles of varying sizes, arranged in a diagonal line. The circles appear to be a design element associated with the brand.

These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process.

The biocompatibility testing of the proposed device was conducted to adequately demonstrate the safety of the device in accordance with the relevant methods cited below:

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

# Table 3: Biocompatibility Test Summary

| SI.<br>No | Test Performed | | Proposed Device | | Result |
|-----------|-----------------------|-------------------|-----------------------------------------|-----------------------------------------|--------|
| | | Standard | Model No. :<br>Surgical Face<br>Mask EL | Model No. :<br>Surgical Face<br>Mask TO | |
| 1. | In-vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Pass |
| 2. | Skin Irritation | ISO 10993-10:2010 | Non-irritating | Non-irritating | Pass |
| 3. | Skin Sensitization | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing | Pass |

## B. Clinical Test Data

Clinical study was not conducted as clinical data is not needed for surgical mask.

## IX. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.