Surgical Face Mask

K203190 · Rfx+Care Manufactoring Co., Ltd. · FXX · Jun 2, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203190
• Device Name: Surgical Face Mask
• Applicant: Rfx+Care Manufactoring Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided as sterile.

Device Story

Surgical face mask; 3-layer flat-pleated design; ear loops; nose-piece. Outer/inner layers: spunbond polypropylene; middle layer: melt-blown polypropylene. Single-use; disposable; sterile. Used in clinical settings for infection control; protects wearer and patient from blood, body fluids, and particulates. Physical barrier function; tested to ASTM F2100 Level 2 standards. EO sterilized.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against ASTM F2100-19, ASTM F1862-17 (fluid resistance), ASTM F2299-2007 (particulate filtration), ASTM F2101-19 (bacterial filtration), and EN 14683:2019 (differential pressure). Biocompatibility confirmed per ISO 10993-1 (cytotoxicity, sensitization, irritation). Sterilization validated per ISO 11135.

Technological Characteristics

3-layer flat-pleated mask. Materials: Spunbond polypropylene (outer/inner), melt-blown polypropylene (middle), polyethylene (nose-piece), polyester/polyurethane (ear loops). ASTM F2100 Level 2 performance. Sterilization: Ethylene oxide (SAL 10^-6). Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for use by patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate materials during infection control practices.

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 (K182515)

Submission Summary (Full Text)

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June 2, 2021

RFX+CARE Manufacturing Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K203190

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 27, 2020 Received: October 27, 2020

Dear James Tsai:

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

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); 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 mediation-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.

Ryan Ortega, 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203190

Device Name Surgical Face Mask

#### Indications for Use (Describe)

The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided as sterile.

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

K203190

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

#### 1. Administrative Information

| Date of Summary prepared | April 23, 2021 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer information | Company: RFX+CARE Manufacturing Co., Ltd.<br>Company address:<br>No. 7 Lanjiang Road, Yuecheng District, Shaoxing,<br>Zhejiang, People's Republic of China<br>Contact person: Zhou Xiufeng<br>Phone: [phone]<br>E-mail: [e-mail] |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.<br>Address: 1713A, 17th Floor, Block A, Zhongguan<br>Times Square, Nanshan District, Shenzhen<br>Contact person: James Tsai<br>E-Mail: [e-mail]; [e-mail] |

### 2. Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|-------------------------------------|
| Trade Name: | Surgical face mask |
| Common name: | Surgical face mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |

# 3. Predicate Device Information

| Sponsor: | Wuhan Dymex Healthcare Co., Ltd. |
|----------------------|-------------------------------------|
| Trade name: | Surgical face mask |
| Common name: | Surgical face mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |

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ll Device Class: 510(K) Number: K182515 Production regulation: | 21 CFR §878.4040

### 4. Device Descriptions

The surgical face mask is provided as sterile, single use, 3 lavers, flat-pleated style with ear loops and nose-piece. The outer layer and inner layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt-blown fabric (polypropylene). 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. This device is not made from any natural rubber latex.

### 5. Indications for Use

The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided as sterile.

| Comparison<br>item | Proposed Device | Predicate Device | Remark |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | RFX+CARE<br>Manufacturing Co., Ltd. | Wuhan Dymex Healthcare<br>Co., Ltd. | / |
| 510k number | K203190 | K182515 | / |
| Product name | Surgical face mask | Surgical face mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intended<br>use &<br>Indications for<br>Use | The surgical face mask is<br>intended to be worn to<br>protect both patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>materials. This face mask is<br>intended for use in infection<br>control practices to reduce<br>the potential exposure to<br>blood and body fluids. This<br>is a single use, disposable<br>device, provided as sterile. | The Surgical Face Masks<br>are 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. These face masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non-sterile. | Same |
| | | | |
| Model and<br>features | D20108<br>Ear Loops, Flat Pleated, 3<br>layers | Ear Loops, Flat Pleated, 3<br>layers | Same |
| Outer layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Melt-blown fabric<br>(polypropylene) | Melt blown polypropylene | Same |
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Nose piece | Polyethylene | Malleable polyethylene wire | Different |
| Ear loops | Polyester & polyurethane<br>filament | Spandex | Different |
| Color | Blue | Yellow | Different |
| Dimension | Mask body: 17.5cm*9.5cm<br>Nose-piece: 8cm-15cm<br>Ear loop: 16.5cm-18cm | Mask body: 17.5cm*9.5cm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Sterile | Non-sterile | Different |
| Sterilization<br>method and<br>S.A.L. | Sterilized by ethylene<br>oxide gas, SAL=10-6 | Not applied | Different |
| Use | Single-use, disposable | Single-use, disposable | Same |
| ASTM F2100<br>level | Level 2 | Level 2 | Same |
| Fluid<br>Resistance<br>Performance | 32 out of 32 pass at 120<br>mmHg<br>(ASTM F1862) | 32 out of 32 pass at 120<br>mmHg | Same |
| Particulate<br>Filtration<br>Efficiency | Pass at 99.69% -99.98%<br>(ASTM F2299) | Pass at 99.7% | Similar |
| Bacterial<br>Filtration<br>Efficiency | Pass at 99.6%-99.8%<br>(ASTM F2101) | Pass at 99.9% | Similar |
| Differential<br>Pressure<br>(Delta-P) | Pass at 4.14-5.90<br>mmH2O/cm²<br>(EN 14683) | Pass at 4.0 mmH₂O/cm² | Similar |
| Flammability<br>16<br>CFR 1610 | Class I<br>(16 CFR Part 1610) | Class I | Same |
| Biocompatibili<br>ty | Conform with ISO10993-1;<br>Non-cytotoxic, Non-<br>sensitizing, Non-irritating | Conform with ISO10993-1;<br>Non-cytotoxic, Non-<br>sensitizing, Non-irritating | Same |
| Item | Proposed device | Result | |
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Pass | |
| Skin<br>Sensitization | Under the conditions of the study, the device is non-sensitizing. | Pass | |
| Skin Irritation | Under the conditions of the study, the device is non-irritating. | Pass | |

#### 6. Summary of Technological Characteristics

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From the comparison table and the gap analysis above, the differences in the materials, colors and sterility status will not raise additional issue for safety and

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effectiveness. Physical performance tests and biocompatibility evaluation have been carried out on the finished devices which include all construction materials and color additives; EO sterilization validation has also been provided to prove the product sterility and performance.

# 7. Non-clinical Test performed on the proposed device

The following performance data of surgical face mask were provided in support of the substantial equivalence determination:

# 7.1 Biocompatibility testing

The biocompatibility evaluation for the surgical face mask was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The outer layer, inner layer and ear loops are considered to be contacted with patient's intact face skin for duration of less than 24 hours. And the biocompatibility evaluation included the following tests:

- · Cytotoxicity
- · Skin Sensitization
- · Skin Irritation

# 7.2 Physical performance testing

Physical performance was conducted, and the results show that the proposed device complies with the following standards:

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

| Item | Subject device | Acceptance criteria | Result |
|--------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------|--------|
| Fluid Resistance<br>Performance (mmHg)<br>(ASTM F 1862-17) | 32 out of 32 pass at 120 mmHg<br>(Statistics of three lots) | 29 out of 32 pass at<br>120 mmHg | Pass |
| Bacterial Filtration<br>Efficiency<br>Performance (%)<br>(ASTM F2101-19) | 99.6%-99.8%<br>(Statistics of three lots) | ≥ 98% | Pass |
| Differential Pressure | 4.14-5.90 mmH2O/cm² | < 6.0mmH2O/cm² | Pass |

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| (Delta-P)<br>(mm H2O/cm2)<br>(EN 14683: 2019) | (Statistics of three lots) | | |
|------------------------------------------------------------------------------|----------------------------------------------|---------|------|
| Particulate Filtration<br>Efficiency<br>Performance (%)<br>(ASTM F2299-2007) | 99.69% -99.98%<br>(Statistics of three lots) | ≥ 98% | Pass |
| Flammability<br>(16 CFR Part 1610) | Class I<br>(Statistics of three lots) | Class I | Pass |

### 7.3 Ethylene oxide Sterilization Validation

The proposed device is also provided for sterilization validation is performed and the results show that the proposed device complies with the following standards:

- · ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- · ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product
- · ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals

### 7.4 Clinical Test Conclusion

No clinical study is included in this submission.

# 8. Conclusions

The conclusion drawn from the non clinical tests demonstrates that the subject device in 510(K) submission k203190 for the Surgical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.