Welspun Health Surgical Mask

K211536 · Welspun India Limited · FXX · Sep 1, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211536
• Device Name: Welspun Health Surgical Mask
• Applicant: Welspun India Limited
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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

Device Story

Three-layer, flat-pleated surgical mask; constructed of spun-bond polypropylene outer/inner layers and melt-blown polypropylene filter layer; features polypropylene-coated aluminum nose strip and knitted elastic ear loops. Device worn over nose and mouth to provide physical barrier against microorganisms, body fluids, and particulates. Used in clinical settings for infection control; operated by healthcare personnel or patients. Provides protection via filtration and fluid resistance; reduces potential exposure to blood and body fluids.

Clinical Evidence

No clinical data; bench testing only. Performance verified against ASTM F2100-19, ASTM F2101-19 (BFE >98%), ASTM F2299 (PFE >99%), 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

Three-layer non-woven polypropylene construction; ultrasonic sealing. Materials: spun-bond polypropylene (outer/inner), melt-blown polypropylene (filter). Nose strip: polypropylene-coated aluminum wire. Ear loops: knitted elastic band. Dimensions: 175x95 mm. Performance: ASTM F2100 Level 3. Non-sterile, single-use, disposable.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings. Disposable, single-use, non-sterile 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

• Disposable Medical Surgical Mask (K202511)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

September 1, 2021

Welspun India Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504

Re: K211536

Trade/Device Name: Welspun Health Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 3, 2021 Received: August 6, 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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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 Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211536

Device Name Welspun Health Surgical Mask

### Indications for Use (Describe)

The Welspun Health Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood & body fluid. 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)

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Image /page/3/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo features a stylized blue "W" on the left, followed by the words "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" are the words "ADVANCED TEXTILES" in a smaller, gray font.

## 510(k) Summary (K211536)

[AS REQUIRED BY 21CFR807.92]

### APPLICANT INFORMATION I.

| Submitter's Name and Address | Welspun India Limited (Advanced Textiles Division),<br>Survey No. 719, Village: Versamedi, Tal: Anjar,<br>District: Kutch , Gujarat, 370110, India | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Fax | [phone] | |
| Contact person | Mr. Satyapriya Dash | |
| Designation | AGM, Head TQM & PD | |
| Contact Number | [phone] | |
| Contact E-mail | satyapriya [e-mail], [e-mail] | |
| Date of Summary Prepared | 03 August 2021 | |

### II. DEVICE DETAILS

| Device Trade Name | Welspun Health Surgical Mask |
|----------------------------|------------------------------|
| Device Common Name | Surgical Face Mask |
| Model(s) | WHSM002ELB, WHSM002ELW |
| Device Classification name | Mask, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |

Welspun India Limited

Corporate Office : Welspun House, 7th Floor, Kamala Mills Compound, Senapat Marg, Lower Parel, Mumbai 400 013, India. T: [phone] / 2490 8000 Fax: [phone]

E-mail: [e-mail] Website: www.welspun.com

Plant I: Survey No. 76, Village Morai, Vapi, District Valsad, Gujarat 396 191, India. T: [phone] Fax: [phone]

Registered Office & Plant II : Survey No. 719, Village: Varsamedi, Tal : Anjar, District : Kutch , Gujarat - 370110, India. T: [phone] Fax: [phone]

## Page 1 of 7

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Image /page/4/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo consists of a blue stylized "W" on the left, followed by the words "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the phrase "ADVANCED TEXTILES" in a smaller, gray font.

### III. PREDICATE DEVICE DETAILS

| Device Trade Name | Disposable Medical Surgical Mask |
|--------------------------|-----------------------------------|
| Device Manufacturer Name | Improve Medical (HuNan) Co., Ltd. |
| 510(k) Number | K202511 |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |

### DEVICE DESCRIPTION IV.

Welspun Health Surgical Mask is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in two colors – medical blue (Model No.: WHSM002ELB) and white (Model No.: WHSM002ELW).

The Welspun Health Surqical Mask is three-layer, flat pleated mask. It is made up of three layers of non-woven polypropylene on automatic mask making machine using the ultrasonic sealing technology.

The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The ear loops are made of round knitted elastic band.

The nose strip 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 aluminium wire.

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

### V. INDICATIONS FOR USE

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

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Image /page/5/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo features a blue stylized "W" symbol on the left. To the right of the symbol is the text "WELSPUN INDIA" in bold, black letters, with the words "ADVANCED TEXTILES" in a smaller font size underneath.

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

## Table 1: General Comparison

| Sl.<br>No | Features compared | Proposed Device | Predicate Device | Result |
|---------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| General Information | | | | |
| 1. | 510(k) Number | K211536 | K202511 | - |
| 2. | Manufacturer | Welspun India Limited | Improve Medical (HuNan) Co.,<br>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. | Indication For Use | The Welspun Health Surgical<br>Mask is intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. The surgical face<br>masks are intended for use in<br>infection control practices to<br>reduce the potential exposure<br>to blood & body fluid. This<br>device is disposable, non-<br>sterile and for single use only. | The Disposable Medical<br>Surgical Masks are intended to<br>be worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material. These<br>face masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a single<br>use, disposable device(s),<br>provided non-sterile. | Same |
| 8. | Model specifications | 3 ply flat pleated masks with<br>ear loops | Ear loops, Flat Pleated, 3<br>layers | Same |
| Materials | | | | |
| 9. | Outer layer | Spun bond polypropylene | Spun bond polypropylene | Same |
| SI.<br>No | Features compared | Proposed Device | Predicate Device | Result |
| 10. | Filter layer | Melt blown polypropylene<br>filter | Melt blown polypropylene filter | Same |
| 11. | Inner layer | Spun bond polypropylene | Spun bond polypropylene | Same |
| 12. | Nose strip | Polypropylene coated single<br>core aluminium wire | Polyethylene coated steel wire | Different(1) |
| 13. | Ear loops | Knitted elastic band | Polyester | Different(2) |
| 14. | Mask style | Flat pleated | Flat pleated | Same |
| 15. | Mask color | Medical Blue, White | Blue | Different(3) |
| 16. | Dimensions | Length- 175 ± 5 mm<br>Width- 95 ± 5 mm<br>Ear Loop Length: 160±10mm | Length-17.5 ± 0.2 cm<br>Width- 9.5 ± 0.2 cm | Similar |
| 17. | OTC Use | Yes | Yes | Same |
| 18. | Sterility | Non-sterile | Non-sterile | Same |
| 19. | Usage | Single use, disposable | Single use, disposable | Same |
| 20. | ASTM F2100 Level | Level 3 | Level 3 | Same |
| | | Non Clinical Testing | | |
| 21. | Fluid resistance | Pass at 160 mmHg | 32 out of 32 pass at 160<br>mmHg | Similar |
| 22. | Flammability | Class I | Class 1 | Same |
| 23. | Particulate Filtration<br>Efficiency (PFE) | >99% | Pass at 98.6% | Similar |
| 24. | Bacterial Filtration<br>Efficiency (BFE) | >98% | Pass at 99.9% | Similar |
| 25. | Differential pressure<br>(ΔΡ) | < 6.0 mm H₂0/cm² | Pass at 3.5 mmH₂0/cm² | Similar |
| 26. | Biocompatibility<br>Testing | Non-Cytotoxic, Non-<br>Sensitizing, Non-Irritating | Under the condition of this study the device is non-cytotoxic, non-sensitizing and non-irritating. | Same |

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Image /page/6/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo consists of a blue stylized "W" on the left, followed by the text "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the text "ADVANCED TEXTILES" in a smaller, lighter font.

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Image /page/7/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo features a stylized blue "W" symbol on the left. To the right of the symbol is the text "WELSPUN INDIA" in bold, black letters, with the words "ADVANCED TEXTILES" in smaller, gray letters underneath.

## VII. JUSTIFICATION FOR DIFFERENCES

The difference is mainly observed in the nose strip, ear loop and color. The differences between proposed device and the predicate device are discussed in detail below and the justification for these are included:

Different(1): The proposed device is using nose strip of polypropylene coated single core aluminium wire whereas the predicate device is using polyethylene coated steel wire.

Different(2): In the proposed device ear loops are made using knitted elastic band not made from natural rubber latex. But, in the predicate device the ear loops are made of polyester.

Different(3): The proposed device is available in two colors - medical blue (Model No.: WHSM002ELB) and white (Model No.: WHSM002ELW) whereas the predicate device is available only in one color- blue.

Justification: Biocompatibility testing in accordance with ISO 10993-1 and performance testing as per ASTM F2100 have been conducted on the final finished device. The proposed device meets the acceptance criteria for level 3 classification as per requirements of performance standard ASTM F2100 and also passes the biocompatibility tests. The safety and effectiveness of Welspun Health Surqical Mask has been demonstrated through the different non-clinical testing performed on these masks. Therefore, the differences between proposed device and the predicate device does not raise any issue regarding the safety or effectiveness of Welspun Health Surgical Mask.

#### VIII. PERFORMANCE DATA

#### A. Non- Clinical Data

### Performance Tests

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

- . Fluid resistance
- . 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:

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Image /page/8/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo consists of a blue stylized "W" on the left, followed by the text "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the text "ADVANCED TEXTILES" in a smaller, gray font.

| 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 WHSM002ELW are given in the table 2 below.

## Table 2: Performance Testing Summary

| Sl.<br>No | Test Performed | Proposed Device | | Acceptance criteria<br>for Level 3<br>Classification as<br>per ASTM F2100<br>Requirements | Result |
|-----------|---------------------------------------------------------------------------------|---------------------------|---------------------------|-------------------------------------------------------------------------------------------|--------|
| | | Model No. :<br>WHSM002ELB | Model No. :<br>WHSM002ELW | | |
| 1. | Fluid resistance<br>ASTM F1862/<br>F1862M-17 | Pass at 160<br>mmHg | Pass at 160<br>mmHg | 29 out of 32 Pass at<br>160 mmHg | Pass |
| 2. | Particulate Filtration<br>Efficiency (PFE)<br>ASTM F2299 / F2299M<br>- 03(2017) | >99% | >99% | ≥ 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 | < 5.0 mm<br>H2O/cm² | < 6.0 mm<br>H2O/cm² | < 6.0 mm H2O/cm² | Pass |
| 5. | Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | Pass |

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Image /page/9/Picture/0 description: The image shows the logo for Welspun India. The logo consists of a blue stylized "W" symbol on the left, followed by the text "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the text "ADVANCED TEXTILES" in a smaller, gray font.

## Biocompatibility

The following tests is performed on the Welspun Health Surgical Mask as per requirements in guidance Surgical

Masks - Premarket Notification [510(k)] Submissions and the FDA guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and is found to be safe with respect to its intended use:

- . In vitro Cytotoxicity
- . Skin irritation
- . 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 10993-10:2010 .. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
## Table 3: Biocompatibility Test Summary

| SI.<br>No | Test<br>Performed | Standard | Proposed Device | | Result |
|-----------|-------------------|-------------------|---------------------------|---------------------------|--------|
| | | | Model No. :<br>WHSM002ELB | Model No. :<br>WHSM002ELW | |
| 1. | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Pass |
| 2. | Irritation | ISO 10993-10:2010 | Non-irritating | Non-irritating | Pass |
| 3. | 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.

### 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.