Disposable Surgical Mask

K203756 · Lucky Textile Industrial(Wuxi) Co., Ltd. · FXX · Jun 10, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203756
• Device Name: Disposable Surgical Mask
• Applicant: Lucky Textile Industrial(Wuxi) Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 10, 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 particulate materials. This device is non sterile and for single use only.

Device Story

Disposable surgical mask; 3-layer flat-pleated design with ear loops and nose piece. Outer/inner layers: spun-bond polypropylene; middle layer: melt-blown polypropylene filter. Nose piece: galvanized wire coated with PE. Used by healthcare workers and patients to reduce transfer of microorganisms, body fluids, and particulates. Provides physical barrier; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only, including ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration), ASTM F2101 (bacterial filtration), EN 14683 (differential pressure), 16 CFR 1610 (flammability), and ISO 10993 (biocompatibility).

Technological Characteristics

3-ply flat-pleated mask. Materials: Spun-bond polypropylene (outer/inner), melt-blown polypropylene (filter), galvanized wire/PE (nose piece), spandex (ear loops). Non-sterile. ASTM F2100 Level 3 compliant. No software or electronic components.

Indications for Use

Indicated for protection of patients and healthcare workers from transfer of microorganisms, body fluids, and particulate materials. For single use only.

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

• Single-use Surgical Mask (K200847)

Submission Summary (Full Text)

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June 10, 2021

Lucky Textile Industrial(Wuxi) Co.,Ltd. Grace Tai General Manager Assistant No.10 Zhuqiao Road, Yixing Economic and Technological Development Zone , Yixing, Jiangsu, China Yixing, Jiangsu 214200 China

Re: K203756

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 8, 2021 Received: May 13, 2021

Dear Grace Tai:

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,

Clarence W. Murray, III, PhD Acting 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) K203756

Device Name Disposable Surgical Mask

#### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| Registration Use (Part 21 CFR 601 Subpart D) | |
|----------------------------------------------|--|
| Over-The-Counter Use (21 CFR 601 Subpart C) | |

__ 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

# 510(k) Number: K203756 Date Prepared: June 10,2021

## 1.Submission Sponsor

| Manufacturer information | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Company: Lucky Textile Industrial(Wuxi) Co.,Ltd. |
| | Company address: No.10 Zhuqiao Road, Yixing<br>Economic and Technological Development<br>Zone, Yixing, Jiangsu, China. |
| | Contact person: Grace Tai |
| | Phone: [phone] |
| | Fax: / |
| | E-mail: [e-mail] |

## 2. Submission correspondent

| Name | Lucky Textile Industrial(Wuxi) Co.,Ltd. |
|-------------------|-----------------------------------------------------------------------------------------------------|
| Address/Post Code | No.10 Zhuqiao Road, Yixing Economic and<br>Technological Development Zone , Yixing, Jiangsu, China. |
| Phone No. | [phone] |
| Contact Person | Grace Tai |
| Email | [e-mail] |

# 3. Device Identification

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Type of 510(k) submission: | Traditional |
|----------------------------|--------------------------|
| Trade Name: | Disposable Surgical Mask |
| Model: | |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4040 |

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## 4. Legally Marketed Predicate Device

| Trade Name | Surgical face mask |
|-------------------|-----------------------------------------|
| Regulation number | 21 CFR 878.4040 |
| Regulation class | II |
| Regulation name | Surgical face mask |
| 510(k) Number | K203756 |
| Product Code | FXX |
| Manufacturer | Lucky Textile Industrial(Wuxi) Co.,Ltd. |

#### 5. Device Description

The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.

#### 6. Intended Use/ 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 materials. This device is non sterile and for single use only.

### 7. Technological characteristics comparison

| Comparison<br>item | Subject Device: Disposable<br>Surgical Mask(K203756) | Predicate Device: Single-<br>use Surgical Mask<br>(K200847) | Comments |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Product<br>Code | FXX | FXX | Same |
| Regulation<br>Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Use<br>(OTC/RX) | OTC | OTC | Same |
| Intended<br>Use & | When properly worn, the<br>surgical face masks are<br>intended to protect both<br>patient and healthcare<br>workers from transfer of<br>microorganisms, body fluids<br>and particulate materials.<br>This device is non sterile and<br>for single use only. | When properly worn, the<br>surgical face masks are<br>intended to protect both<br>patient and healthcare<br>workers from transfer of<br>microorganisms, body<br>fluids and airborne<br>particles. This device is<br>non-sterile and for<br>single use only. | Same |
| Comparison<br>item | Subject Device: Disposable<br>Surgical Mask (K203756) | Predicate Device: Single-<br>use Surgical Mask<br>(K200847) | Comments |
| Indications<br>for Use | When properly worn, the surgical face masks are<br>intended to protect both patient and healthcare<br>workers from transfer of microorganisms, body<br>fluids and particulate materials. This device is<br>non sterile and for single use only. | When properly worn, the surgical face masks are<br>intended to protect both patient and healthcare<br>workers from transfer of microorganisms, body<br>fluids and airborne particles. This device is<br>non-sterile and for single use only. | |
| Design<br>feature | 3 Ply, Ear Loops,<br>Flat-Pleated Style | 3 Ply, Ear Loops, Flat-<br>Pleated Style | Same |
| Usage | Single use | Single use | Same |
| Color | Blue | White | Different<br>Issue 1<br>Similar |
| Size | $9.5cm \pm 0.5cm$ (Width)<br>$17.5cm \pm 0.5cm$ (Length) | $9.0cm \pm 0.5cm$ (Width)<br>$17.5cm \pm 0.5cm$ (Length) | Issue 2 |
| Sterilization<br>Status | Non-sterile | Non-sterile | Same |
| Material | Outer layer:<br>Spun-bond polypropylene | Outer layer:<br>Spun-bond polypropylene | Same |
| | Middle layer:<br>Melt blown polypropylene<br>filter | Middle layer:<br>Melt blown polypropylene<br>filter | Same |
| | Inner layer:<br>Spun-bond polypropylene | Inner layer:<br>Spun-bond polypropylene | Same |
| | Nose piece:<br>Single Galvanize<br>Wire, Coated By PE | Nose piece:<br>Single Galvanize Wire,<br>Coated By PE | Same |
| Comparison<br>item | Subject Device: Disposable<br>Surgical Mask(K203756) | Predicate Device: Single-<br>use Surgical Mask<br>(K200847) | Comments |
| | Ear-Piece: Spandex | Ear-Piece: not made with<br>natural rubber latex | Same |
| ASTM F<br>2100 Level | Level 3 | Level 2 | Issue 3 |
| Fluid<br>Resistance<br>Performance<br>ASTM F<br>1862-13 | Lot 1: 32 Out of 32 pass at 160<br>mmHg<br>Lot 2: 32 Out of 32 pass at 160<br>mmHg<br>Lot 3: 32 Out of 32 pass at 160<br>mmHg | 30 Out of 32 pass at 120<br>mmHg | Different<br>Issue 4 |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F<br>2299 | Lot 1:99.8%<br>Lot 2:99.9%<br>Lot 3: 99.9% | 99.9% | Same |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F<br>2101 | Lot 1: > 99.9%<br>Lot 2: > 99.9%<br>Lot 3: > 99.9% | > 99.9% | Same |
| Differential<br>Pressure<br>(Delta P) EN<br>14683:2019+<br>AC : 2019 | Lot 1: 3.4 mmH20/cm²<br>Lot 2: 3.5 mmH20/cm²<br>Lot 3: 3.3 mmH20/cm² | 3.0 mmH20/cm² | Same |
| Flammability<br>16CFR 1610 | Lot 1: Class 1<br>Lot 2: Class 1<br>Lot 3: Class 1 | Class 1 | Same |
| Cytotoxicity | Comply with ISO 10993-5<br>Non cytotoxic | Comply with ISO 10993-5<br>Non cytotoxic | Same |
| Irritation | Comply with ISO 10993-10<br>Non irritating | Comply with ISO 10993-<br>10<br>Non irritating | Same |
| Sensitization | Comply with ISO 10993-10<br>Non sensitizing | Comply with ISO 10993-<br>10<br>Non sensitizing | Same |

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Discuss of Comments:

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lssue 1: The composition of colorants are Phthalocyanine Blue BGS (CAS No.147-14-8) and Pigment Violet 23 (CAS No. 6358-30-1), we provided the MSDS of color additive used in our manufacturing process.

lssue 2: The width dimension of subject is a little longer than that of predicate device, this difference does not affect the safety and effectiveness.

lssue 3: Subject device comply with ASTM F 2100 Level 3, and we have done corresponding performance tests.

lssue 4:The test result of Fluid Resistance Performance meets the requirement of ASTM F 2100 Level 3.

## 8. Summary of Non-clinical Testing

Non-clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.

Standards: List as Applicable

- ASTM F2100-19 Standard Specification For Performance of Materials used in Medical Face Masks.
- ASTM F1862-13 Standard Test Method For Resistance of Medical Face Masks to Penetration by Synthetic Blood.
- ASTM F2299-03 Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR 1610 Standard For The Flammability Of Clothing Textiles.
- 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.

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| Test Methodology | Purpose | Acceptance<br>Criteria | Results |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance<br>Performance<br>(ASTM F1862) | The test method is used to<br>evaluate the resistance of<br>medical face masks to<br>penetration by the impact of a<br>small volume(~2 mL) of high-<br>velocity stream of synthetic<br>blood. The pass/fail<br>determinations are based on<br>visual detection of synthetic<br>blood penetration. | 29 Out of 32 pass at<br>160 mmHg | Lot 1: 32 Out of 32<br>pass at 160 mmHg<br>Lot 2: 32 Out of 32<br>pass at 160 mmHg<br>Lot 3: 32 Out of 32<br>pass at 160 mmHg<br>Pass |
| Particulate Filtration<br>Efficiency<br>(ASTM F2299) | The purpose of this test<br>method is to measure the initial<br>partical filtration efficiency of<br>materials using monodispersed<br>aerosols containing suspended<br>latex spheres particulates of<br>0.1μm diameter. | ≥ 98% | Lot 1:99.8%<br>Lot 2:99.9%<br>Lot 3: 99.9%<br>Pass |
| Bacterial Filtration<br>Efficiency<br>(ASTM F2101) | The purpose of this test<br>method is to determine the<br>bacterial filtration efficiency of<br>the mask as specified in ASTM<br>F2101. | ≥ 98% | Lot 1: > 99.9%<br>Lot 2: > 99.9%<br>Lot 3: > 99.9%<br>Pass |
| Differential Pressure<br>(EN 14683:2019) | The purpose of this test s to<br>measure the differential<br>pressure between the inside<br>and outside of the mask. | < 6.0 mmH20/cm² | Lot 1: 3.4 mmH20/cm²<br>Lot 2: 3.5 mmH20/cm²<br>Lot 3: 3.3 mmH20/cm²<br>Pass |
| Flammability<br>(16 CFR 1610) | The purpose of this test<br>method is to determine the<br>flammability charateristics of<br>the mask as specified in 16<br>CFR Part 1610. Materials in<br>the construction of medical<br>face masks shall meet the<br>requirements for Class 1,<br>normal flammability specified in<br>16 CFR Part 1610. | Class 1 | Lot 1: Class 1<br>Lot 2: Class 1<br>Lot 3: Class 1<br>Pass |

| Table 2: Performance Characteristic Comparison | | |
|------------------------------------------------|--|--|
|------------------------------------------------|--|--|

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| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------|
| Cytotoxicity | The purpose of the<br>test is to determine<br>the biological reactivity<br>of a mammalian cell<br>culture (mouse<br>fibroblast L929cells) in<br>response to the test<br>article. | Non-Cytotoxic | Under the conditions of<br>the study, non-cytotoxicity<br>effect |
| Irritation | To evaluate the potential<br>skin irritation caused by<br>the extraction of the test<br>article extract contacting<br>with the skin surface of<br>rabbits. | NonSensitizing | Under the conditions of the<br>study, non-irritation |
| Sensitization | To evaluate the potential<br>of test article extracts to<br>cause skin sensitization<br>in the guinea pig<br>according to GPMT<br>method. | Non-Irritating | Under the conditions of the<br>study, non-sensitization |

## Table 3: Biocompatibility Comparison

## 9. Brief discussion of clinical tests

No clinical tests were performed, or discuss as applicable.

#### 10. Conclusions

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K203756, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200847.