Surgical Face Mask

K203161 · Wuhan Raytex Protection Co., Ltd. · FXX · Jan 20, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K203161
• Device Name: Surgical Face Mask
• Applicant: Wuhan Raytex Protection Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jan 20, 2022
• 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 material. This device is non-sterile and for single use only.

Device Story

Surgical face mask; flat-pleated, 3-layer design; ear loops; nose piece. Outer/inner layers: polypropylene; middle layer: melt-blown polypropylene filter. Used by healthcare workers and patients in clinical settings to reduce exposure to microorganisms, body fluids, and particulates. Device acts as physical barrier. Non-sterile; single-use. Performance meets ASTM F2100-19 Level 1 standards.

Clinical Evidence

Bench testing only. Evaluated against ASTM F2100-19 standards: Synthetic blood penetration (ASTM F1862, 80 mmHg), Particulate Filtration Efficiency (ASTM F2299, >96%), Bacterial Filtration Efficiency (ASTM F2101, >99%), Differential Pressure (EN 14683, ~3.9 mmH2O/cm²), and Flammability (16 CFR 1610, Class 1). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

3-layer flat-pleated mask. Materials: Polypropylene (outer/inner), melt-blown polypropylene (filter), spandex/nylon (ear loops), PE-coated galvanized wire (nose piece). ASTM F2100-19 Level 1 performance. Non-sterile. No electronic components or software.

Indications for Use

Indicated for adults to protect patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. For single-use, non-sterile, over-the-counter use.

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

• Medical Face Mask (K202061)

Submission Summary (Full Text)

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January 20, 2022

Wuhan Raytex Protection CO., LTD Maggie Yao General Manager RM1201,Mingchuang Building,Greenland,Heping Avenue, Wuchang District Wuhan, Hubei 430060 China

Re: K203161

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 25, 2021 Received: December 16, 2021

Dear Maggie Yao:

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 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) K203161

Device Name Surgical face mask

Indications for Use (Describe)

When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is 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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### 510(k) Summary

### Summary Prepared Date

19 January 2022

#### Submitter Information 1.

Sponsor Name: WUHAN RAYTEX PROTECTION CO., LTD

Address: RM1201,Mingchuang Building,Greenland,Heping Avenue,Wuchang District,Wuhan,Hubei

Province,430060,China.

Contact Person:Maggie Yao (General Manager)

Phone: [phone]

Fax: [phone]

E-mail:[e-mail]

#### 2. Subject Device Information

| Type of 510(k): | Traditional |
|----------------------|--------------------|
| Common Name: | Surgical face mask |
| Trade Name: | Surgical face mask |
| 510(k) number: | K203161 |
| Classification Name: | Mask,Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | Class II |

#### 3. Predicate Device Information

| Sponsor: | Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
|--------------------|-------------------------------------------------------|
| Common Name: | Medical Face Mask |
| Trade Name: | Medical Face Mask |
| 510(k) number: | K202061 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |

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Regulation Class: Class II

#### 4. Device Description

The surgical face masks are non-sterile, 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 Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.

#### 5. 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 material. This device is non sterile and for single use only.

### 6. Summary of Comparison and Technological Characteristics

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------|
| Product Name | Surgical face mask | Medical face mask | -- | |
| 510(k) number | K203161 | K202061 | -- | |
| General Comparison | | | | |
| Intended 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 material.<br>This<br>device is non-sterile and for<br>single use only. | The medical face mask is<br>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>materials in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. It is for single-use<br>and provided non-sterile. | Same | |
| Model | Flat type | Flat Pleated | Same | |
| Design features | Ear loop | Ear loop | Same | |
| Layers | 3 | 3 | Same | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
| Target population | Adults | Adults | Same | |
| Material | Outer facing layer | polypropylene | polypropylene | Same |
| | Middle layer | Melt blown polypropylene filter | Melt blown polypropylene | Same |
| | Inner facing layer | polypropylene | polypropylene | Same |
| | Nose piece | Single Galvanize Wire, Coated by PE | Polypropylene coated steel wire | Note 1 |
| | Ear loops | Spandex and nylon | Spandex and nylon | Same |
| Color | Blue | Blue | Same | |
| Dimension (Width) | 9.5cm ± 0.5cm | 9.5cm | Same | |
| Dimension (Length) | 17.5cm ± 0.5cm | 17.5cm | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use | Single Use | Same | |
| ASTM F2100 Level | Level 1 | Level 1 | Same | |
| Synthetic Blood<br>Penetration<br>Resistance<br>ASTM F 1862 | Lot 1: 32 Out of 32 pass at80 mmHg<br>Lot 2: 32 Out of 32 pass at 80 mmHg<br>Lot 3: 32 Out of 32 pass at80 mmHg | 80 mmHg | Same | |
| Particulate Filtration<br>Efficiency<br>ASTM F 2299 | Lot 1:Average 96.6%<br>Lot 2:Average 96.1 %<br>Lot 3:Average 96.2% | Average 96.09% | Same | |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101 | Lot 1: Average 99.5%<br>Lot 2: Average 99.4%<br>Lot 3: Average 99.4% | Average 99.8% | Same | |
| Differential Pressure<br>(Delta P)<br>EN 14683:2019+AC: | Lot 1: Average 3.9 mmH2 0/cm²<br>Lot 2: Average 3.8 mmH2 | Average 3.9 mmH2 0/cm² | Same | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
| 2019 | 0/cm²<br>Lot 3: Average 4.0 mmH2<br>0/cm² | | | |
| 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- 10<br>Non irritating | Same | |
| Sensitization | Comply with ISO 10993-10<br>Non sensitizing | Comply with ISO 10993- 10<br>Non sensitizing | Same | |

### Table 1 - General Comparison

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WUHAN RAYTEX PROTECTION CO., LTD Sponsor:

Subject Device: File No.:

Surgical face mask,model:Flat type 510(k) submission report,

510(k) Submission number: K203161

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WUHAN RAYTEX PROTECTION CO., LTD Sponsor:

Subject Device: Surgical face mask,model:Flat type

> File No.: 510(k) submission report,

510(k) Submission number: K203161

Note 1: The nose piece material of the subject device is Single Galvanize Wire, Coated by PE. The predicate device uses polypropylene coated steel wire. The nose piece does not directly contact the user ' s skin. Biocompatibility testing was conducted on the final device. Performance testing was conducted according to ASTM F2100-19.

Otherwise, all of the specifications and materials of the subject device, Surgical face mask, are the same as the predicate device K202061.

### Table 2 - Performance Testing

### We have tested three lots of product. The data below is one of these performance tests.

Surgical face mask has been evaluated the safety and performance by lab bench testing according to the following standards:

- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by ynthetic blood (Horizontal projection of fixed volume at a known velocity)
- 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.

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- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- Determine breathing resistance or differential pressure as directed in EN 14683:2019,AnnexC

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

| Item | Test Method | Acceptance Criteria | Result |
|------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Fluid<br>Resistance<br>Performance<br>(mmHg) | ASTM F1862 | (A) There are no burn<br>times; or(B) There is only<br>one burn time and it is<br>equal to or greater than 3.5<br>seconds; or(C) The average<br>burn time of<br>two or more specimens is<br>equal to or greater than 3.5<br>seconds. | Lot 1: 32 Out of 32 pass<br>at 80 mmHg<br>Lot 2: 32 Out of 32 pass<br>at 80 mmHg<br>Lot 3: 32 Out of 32 pass<br>at 80 mmHg |
| Particulate<br>Filtration<br>Efficiency<br>Performance (%) | ASTM F2299 | ≥ 95% | Lot 1:Average 96.6 % Lot<br>2:Average 96.1% Lot 3:Average<br>96.2% |
| Bacterial Filtration<br>Efficiency<br>Performance (%) | ASTM F2101 | ≥ 95% | Lot 1: Average 99.5%<br>Lot 2: Average 99.4%<br>Lot 3: Average 99.4% |
| Flammability<br>class | 16 CFR 1610 | Class 1 | Lot 1: Class 1<br>Lot 2: Class 1<br>Lot 3: Class 1 |
| Differential<br>Pressure<br>(Delta-P)<br>(mm H2O/cm2) | ASTM F2100-19<br>EN<br>14683 :2019+A<br>C (2019)(E),<br>Annex C | < 5.0 mmH20/cm² | Lot 1: Average 3.9<br>mmH2O/cm²<br>Lot 2: Average 3.8<br>mmH2O/cm²<br>Lot 3: Average 4.0<br>mmH2O/cm² |

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WUHAN RAYTEX PROTECTION CO., LTD Sponsor: Subject Device: Surgical face mask,model:Flat type File No.: 510(k) submission report,

510(k) Submission number: K203161

## Table 3 - Biocompatibilitv Testing

- During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.
ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity

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

Sensitization.

| Test item | Test method | Acceptance Criteria | Result |
|-----------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| In Vitro Cytotoxicity | ISO 10993-5: 2009<br>MTT method. | The 50% extract of the test<br>article should have at least the<br>same or a higher viability than<br>the 100% extract.<br>Otherwise the test should be<br>repeated. The lower the<br>Viab. % value, the higher the<br>cytotoxic potential of the test<br>article is. If viability is reduced<br>to <70% of the blank, it has a<br>cytotoxic potential.<br>The Viab.% of the 100% extract<br>of the test article is the final<br>result. | Under the<br>conditions of<br>the test, the<br>test article<br>was found to<br>be non-<br>cytotoxic |
| Skin Sensitization | ISO 10993-10:2010<br>Guinea Pig<br>Maximization | Magnusson and Kligman<br>grades of 1 or greater in the<br>test group generally indicate<br>sensitization, provided<br>grades of less than 1 are<br>seen in control animals. If<br>grades of 1 or greater are<br>noted in control animals, then<br>the reactions of test animals<br>which exceed the most<br>severe reaction in control<br>animals are presumed to be<br>due to sensitization. If the | Under the<br>conditions of<br>the test, the<br>test article<br>was found to<br>be non-<br>sensitizing |
| 510(k) Submission number: K203161 | | response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals. | |
| Skin Irritation | ISO 10993-10:2010<br>Skin Irritation Test | Use only (24±2) h, (48±2) h and (72±2) h observations for calculation. After the 72 h grading, all erythema grades plus oedema grades (24±2)h, (48±2) h and (72±2) h were totalled separately for each test article and blank for each animal. The primary irritation score for an animal was calculated by dividing the sum of all the scores by 6 (two test/observation sites, three time points). To obtain the primary irritation index for the test article, add all the primary irritation scores of the individual animals and divide by the number of animals. When blank or negative control was used, calculate the primary irritation score for the controls and subtract that score from the score using the test material to obtain the primary irritation score. | Under the conditions of the test, the test article was found to be non-irritating |

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WUHAN RAYTEX PROTECTION CO., LTD Sponsor:

Subject Device: Surgical face mask,model:Flat type

510(k) submission report, File No.:

510(k) Submission number: K203161

### 7. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203161, the surgical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202061.