Magnum

K220670 · Magnum Health and Safety Pvt, Ltd. · FXX · Jun 28, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220670
• Device Name: Magnum
• Applicant: Magnum Health and Safety Pvt, Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

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

Device Story

Magnum surgical face masks are disposable, non-sterile, 3-ply masks designed to cover the user's nose and mouth. Construction includes inner and outer layers of spun-bond polypropylene and a middle layer of melt-blown filter media. Models 2200/2300 utilize knitted elastic ear loops; models 1200/1300 utilize tie-back strings made of spun-bond polypropylene. A PVC-coated aluminum nose wire allows for facial contouring. Used in clinical settings by healthcare workers and patients to provide a barrier against blood, body fluids, and microorganisms. The device is worn by the user to reduce infection transmission risk. Effectiveness is verified through fluid resistance, filtration efficiency, and flammability testing.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included fluid resistance (ASTM F1862), PFE (ASTM F2299), BFE (ASTM F2101), differential pressure (EN 14683), and flammability (16 CFR 1610). Biocompatibility testing included cytotoxicity (ISO 10993-5), skin irritation (ISO 10993-23), and skin sensitization (ISO 10993-10). All tests passed.

Technological Characteristics

3-ply construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter). PVC-coated aluminum nose wire. Ear loops (knitted elastic) or tie-backs (spun-bond polypropylene). Dimensions: 172x95 mm. Non-sterile, single-use. Meets ASTM F2100-19 Level 2 and 3 standards.

Indications for Use

Indicated for use by patients and healthcare workers to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices. Disposable, non-sterile, single-use device.

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

• Surgical Face Mask (K212368)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

June 28, 2022

Magnum Health And Safety Pvt Ltd % Manoj Zacharias US Agent Liberty Management Group Ltd. 75 Executive Drive, Suite 114 Aurora, Illinois 60504

Re: K220670

Trade/Device Name: Magnum Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 31, 2022 Received: June 2, 2022

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.

{1}------------------------------------------------

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

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

For comprehensive regulatory information about 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.

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K220670

Device Name Magnum

Indications for Use (Describe)

When properly worn, the surgical face masks are intent and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.

| 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

### I. APPLICANT INFORMATION

| Submitter's Name | Magnum Health And Safety Pvt Ltd |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | Unit No. 21, 22, 23, Supreme Industrial Estate, Lucky<br>Compound, Near Bhajanlal Dairy, Chinchoti Naka, Village<br>Devdal, Taluka - Vasai, Dist - Palghar, Maharashtra,<br>India - 401208 |
| Name of Contact Person | Mr. Rakesh Bhagat |
| Designation | Director |
| Contact Number | [phone] |
| Contact E-mail | [e-mail] |
| Date of Summary Prepared | 11 February 2022 |

### II. DEVICE DETAILS

| Device Trade Name | Magnum |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name | Surgical Face Mask |
| Model(s) | 2200 (Level 2, 3ply with ear loop)<br>2300 (Level 3, 3ply with ear loop)<br>1200 (Level 2, 3ply with tie back)<br>1300 (Level 3, 3ply with tie back) |
| Device Classification name | Mask, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |

{4}------------------------------------------------

#### PREDICATE DEVICE DETAILS III.

| Device Trade Name | Surgical Face Mask | |
|--------------------------|--------------------------------------------|-------------------------------------------|
| Device Manufacturer Name | Anhui Tiankang Medical Technology Co.,Ltd. | |
| Model(s) | Model No. | Model Description |
| | WKKZ.R.LEVEL1-001 | Level 1, Ear loop, Flat pleated, 3 layers |
| | WKKZ.R.LEVEL2-001 | Level 2, Ear loop, Flat pleated, 3 layers |
| | WKKZ.R.LEVEL3-001 | Level 3, Ear loop, Flat pleated, 3 layers |
| | WKKZ.J.LEVEL1-001 | Level 1, Tie-on, Flat pleated, 3 layers |
| | WKKZ.J.LEVEL2-001 | Level 2, Tie-on, Flat pleated, 3 layers |
| | WKKZ.J.LEVEL3-001 | Level 3, Tie-on, Flat pleated, 3 layers |
| 510(k) Number | K212368 | |
| Regulation Number | 21 CFR 878.4040 | |
| Device Class | Class II | |
| Product Code | FXX | |

#### DEVICE DESCRIPTION IV.

Magnum is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in a single color – blue.

The inner and outer layers are made of spun-bond polypropylene non-woven fabric, and the middle layer is made of melt blown filter media. 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 PVC coated aluminum wire.

The model 2200 is level 2 surgical face mask and the model 2300 is level 3 surgical face mask. Both these models are provided with ear loops to hold and fit the face mask in place over the user's mouth and nose. The ear loops are made of knitted elastic.

The model 1200 is level 2 surgical face mask and the model 1300 is level 3 surgical face mask. Both these models are provided with tie back to hold and fit the face mask in place over the user's mouth and nose. The tie back string is made of spun-bond polypropylene non-woven fabric.

The dimensions of the test item are: length- 172 ± 3 mm and width- 95 ± 3 mm.

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

{5}------------------------------------------------

#### INTENDED USE V.

The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This device is disposable, non-sterile and for single use only.

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

### Table 1: General Comparison

| SI.<br>No | Features<br>compared | Proposed Device | Predicate Device | Result | |
|----------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------|
| General Information | | | | | |
| 1. | 510(k) Number | | K212368 | - | |
| 2. | Manufacturer | Magnum Health And Safety Pvt<br>Ltd | Anhui Tiankang Medical<br>Technology 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 | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only. | The Surgical Face Masks 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | Same | |
| SI.<br>No | Features<br>compared | Proposed Device | Predicate Device | Result | |
| 8. | Model specifications | 2200 (Level 2, Ear Loops, Flat<br>Pleated, 3 layers) | WKKZ.R.LEVEL2-001 (Level 2,<br>Ear loop, Flat pleated, 3 layers) | Same | |
| | | 2300 (Level 3, Ear Loops, Flat<br>Pleated, 3 layers) | WKKZ.R.LEVEL3-001 (Level 3,<br>Ear loop, Flat pleated, 3 layers) | | |
| | | 1200 (Level 2, Tie back, Flat<br>Pleated, 3 layers) | WKKZ.J.LEVEL2-001 (Level 2,<br>Tie-on, Flat pleated, 3 layers) | | |
| | | 1300 (Level 3, Tie back, Flat<br>Pleated, 3 layers) | WKKZ.J.LEVEL3-001 (Level 3,<br>Tie-on, Flat pleated, 3 layers) | | |
| Materials | | | | | |
| 9. | Outer layer | Spun bond polypropylene | Spun-bond polypropylene | Same | |
| 10. | Filter layer | Melt blown filter media | Melt blown polypropylene filter | Same | |
| 11. | Inner layer | Spun bond polypropylene | Spun-bond polypropylene | Same | |
| 12. | Nose wire | PVC coated aluminum wire | PP coated steel wire | Different1 | |
| 13. | Ear loop | For model(s): 2200 and<br>2300<br>Ear Loop: Knitted elastic | For model(s):<br>WKKZ.R.LEVEL2-001 and<br>WKKZ.R.LEVEL3-001<br>Ear Loop: Nylon and spandex | Different2 | |
| 14. | Tie back | For model(s): 1200 and<br>1300 | For model(s):<br>WKKZ.J.LEVEL2-001 and<br>WKKZ.J.LEVEL3-001 | Same | |
| | | Tie back: Spun-bond<br>polypropylene non-woven<br>fabric | Tie back: PP nonwoven | | |
| 15. | Mask color | Blue | Blue | Same | |
| 16. | Dimensions | Length- 172 ± 3 mm<br>Width- 95 ± 3 mm | Length- 175 ± 5 mm<br>Width- 95 ± 2.85 mm | Similar | |
| 17. | OTC Use | Yes | Yes | Same | |
| 18. | Sterility | Non-sterile | Non-sterile | Same | |
| 19. | Reusability | Single use | Single use | Same | |
| 20. | ASTM F2100 Level | Level 2 & 3 | Level 2 & 3 | Same | |
| SI.<br>No | Features<br>compared | Proposed Device | Predicate Device | Result | |
| Non Clinical Testing | | | | | |
| 21. | Fluid resistance | Level 2 models<br>Pass at 120 mmHg | Level 2 models<br>Pass at 120 mmHg | Same | |
| | | Level 3 models<br>Pass at 160 mmHg | Level 3 models<br>Pass at 160 mmHg | Same | |
| 22. | Flammability | All models – Class I | All models – Class I | Same | |
| 23. | Particulate Filtration<br>Efficiency (PFE) | Level 2 models<br>Pass at >98% | Level 2 models<br>Pass at ≥98% | Same | |
| | | Level 3 models<br>Pass at >98% | Level 3 models<br>Pass at ≥98% | Same | |
| 24. | Bacterial Filtration<br>Efficiency (BFE) | Level 2 models<br>Pass at >98% | Level 2 models<br>Pass at ≥98% | Same | |
| | | Level 3 models<br>Pass at >98% | Level 3 models<br>Pass at ≥98% | Same | |
| 25. | Differential pressure<br>(ΔΡ) | Level 2 models<br>Pass at < 6.0 mmH20/cm2 | Level 2 models<br>Pass at < 6.0 mmH20/cm2 | Same | |
| | | Level 3 models<br>Pass < 6.0 mmH20/cm2 | Level 3 models<br>Pass < 6.0 mmH20/cm2 | Same | |
| 26. | Biocompatibility Testing | In vitro<br>cytotoxicity | Non-cytotoxic under the<br>conditions of the study | All models non-cytotoxic under<br>the conditions of the study | Same |
| 27. | | Skin Irritation | Non-irritating under the<br>conditions of the study | All models non-irritating under<br>the conditions of the study | Same |
| 28. | | Skin<br>Sensitization | Non-sensitizer under the<br>conditions of the study | All models non-sensitizer under<br>the conditions of the study | Same |

{6}------------------------------------------------

{7}------------------------------------------------

## VII. JUSTIFICATION FOR DIFFERENCES

The difference is mainly observed in the nose wire and ear loop. The differences between proposed device and the predicate device are discussed in detail below and the justifications are included:

Different1: The proposed device is using nose wire of PVC coated aluminum wire whereas the predicate device is using nose wire made of PP coated steel wire.

Different²: In the proposed device ear loop for models 2200 and 2300 is made of knitted elastic. But, in the predicate device the ear loop is made of nylon and spandex.

Justification: The safety and effectiveness of Magnum has been demonstrated through the different performance and biocompatibility testing performed on these masks. Therefore, the differences between

{8}------------------------------------------------

proposed device and the predicate device does not raise any issue regarding the safety or effectiveness of Magnum.

#### VIII. PERFORMANCE DATA

#### A. Non- Clinical Data

### Performance Tests

Magnum is subjected to the following performance tests according to the requirements provided in the guidance Surgical Masks - Premarket Notification [510(k)] Submissions and is found to be safe and efficient with respect to its intended use:

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

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

| ASTM F2100-19 | : | Standard Specification for Performance of Materials Used in Medical Face<br>Masks |
|---------------------------------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F2101-19 | : | Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE)<br>Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus<br>Aureus. |
| ASTM F2299/F2299M -<br>03(2017) | : | Standard Test Method for Determining the Initial Efficiency of Materials Used<br>in Medical Face Masks to Penetration by Particulates Using Latex Spheres |
| EN 14683 (Annex C):<br>2019 | : | Medical Face Masks – Requirements And Test Methods |
| ASTM F1862/F1862M-<br>17 | : | Standard Test Method for Resistance of Medical Face Masks to Penetration<br>by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known<br>Velocity) |
| 16 CFR 1610 | : | Standard for the Flammability of clothing textiles |

The summary of performance testing on the proposed device models 1300 and 2300 are qiven in the table 2 and the summary of performance testing on the proposed device models 1200 and 2200 are given in the table 3.

{9}------------------------------------------------

| SI.<br>No | Test Performed | Proposed Device | | Acceptance<br>criteria for<br>Level 3<br>Classification | Result |
|-----------|---------------------------------------------------------------------------|---------------------|---------------------|---------------------------------------------------------|--------|
| | | Model 1300 | Model 2300 | | |
| 1. | Fluid resistance<br>ASTM F1862/ F1862M-17 | Pass at 160<br>mmHg | Pass at 160<br>mmHg | Pass at 160<br>mmHg | Pass |
| 2. | Particulate Filtration Efficiency (PFE)<br>ASTM F2299 / F2299M - 03(2017) | > 98% | > 98% | ≥ 98% | Pass |
| 3. | Bacterial Filtration Efficiency (BFE)<br>ASTM F2101-19 | > 98% | > 98% | ≥ 98% | Pass |
| 4. | Differential pressure (ΔP)<br>EN 14683 (Annex C): 2019 | < 3.0<br>mmH2O/cm² | < 3.0<br>mmH2O/cm² | < 6.0<br>mmH2O/cm² | Pass |
| 5. | Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | Pass |

# Table 2: Performance Testing Summary for Models 1300 and 2300

Table 2: Performance Testing Summary for Models 1200 and 2200

| Sl.<br>No | Test Performed | Proposed Device | | Acceptance<br>criteria for<br>Level 2<br>Classification | Result |
|-----------|---------------------------------------------------------------------------|---------------------|---------------------|---------------------------------------------------------|--------|
| | | Model 1200 | Model 2200 | | |
| 1. | Fluid resistance<br>ASTM F1862/ F1862M-17 | Pass at 120<br>mmHg | Pass at 120<br>mmHg | Pass at 120<br>mmHg | Pass |
| 2. | Particulate Filtration Efficiency (PFE)<br>ASTM F2299 / F2299M - 03(2017) | > 98% | > 98% | ≥ 98% | Pass |
| 3. | Bacterial Filtration Efficiency (BFE)<br>ASTM F2101-19 | > 98% | > 98% | ≥ 98% | Pass |
| 4. | Differential pressure (ΔP)<br>EN 14683 (Annex C): 2019 | < 3.0<br>mmH2O/cm² | < 3.0<br>mmH2O/cm² | < 6.0 mm<br>H2O/cm² | Pass |
| 5. | Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | Pass |

{10}------------------------------------------------

## Biocompatibility

The materials used in the Magnum are biocompatiblity tests mentioned in the guidance Surgical Masks - Premarket Notification [510(k)] Submissions:

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

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 10993-23: 2021 | : | Biological Evaluation Of Medical Devices - Part 23: Tests For Irritation. |
| ISO 10993-10: 2021 | : | Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization. |

## Table 3: Biocompatibility Test Summary

| SI.<br>No | Test Performed | Standard | Proposed Device | | Result |
|-----------|-----------------------|-------------------|-----------------|-----------------|--------|
| 1. | In-vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Pass |
| 2. | Skin Irritation | ISO 10993-23:2021 | Non-irritating | Non-irritating | Pass |
| 3. | Skin Sensitization | ISO 10993-10:2021 | Non-sensitizing | Non-sensitizing | Pass |

#### B. Clinical Test Data

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

#### CONCLUSION IX.

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.