Disposable Medical Face Mask

K202710 · Wanxinda (Guangzhou) Technology Product Co., Ltd. · FXX · Mar 9, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202710
• Device Name: Disposable Medical Face Mask
• Applicant: Wanxinda (Guangzhou) Technology Product Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use , disposable device, provided nonsterile.

Device Story

Disposable, three-layer, non-sterile face mask; worn over nose and mouth to provide barrier protection against microorganisms, body fluids, and particulates. Constructed with inner/outer spun-bond polypropylene layers and middle melt-blown polypropylene filter layer. Secured via elastic spandex ear loops; includes polypropylene-encased steel wire nose piece for fit. Used in clinical or general settings for infection control. Healthcare personnel or patients don the mask manually. Output is physical barrier protection; reduces potential exposure to blood/body fluids. Benefits include mitigation of cross-contamination risk between wearer and environment.

Clinical Evidence

No clinical data. Bench testing only. Performance metrics: Fluid resistance (80 mmHg), Particulate Filtration Efficiency (99.8%), Bacterial Filtration Efficiency (99.8%), Differential Pressure (< 5.0 mm H2O/cm²), and Flammability (Class 1). Biocompatibility testing per ISO 10993-5 and ISO 10993-10 confirmed non-cytotoxic, non-irritating, and non-sensitizing properties.

Technological Characteristics

Three-layer flat mask; inner/outer layers: spun-bond polypropylene; middle layer: melt-blown polypropylene. Nose piece: polypropylene with steel wire. Ear loops: spandex. Dimensions: 175mm x 95mm. Non-sterile. Performance meets ASTM F2100-19 Level 1 requirements. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use by patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate material 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 (K133070)

Submission Summary (Full Text)

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March 9, 2021

Wanxinda (Guangzhou) Technology Product Co., Ltd % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China

Re: K202710

Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 7, 2020 Received: September 16, 2020

Dear Joyce Yang:

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 801and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing 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 (OS) 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K202710

Device Name Disposable Medical Face Mask

### Indications for Use (Describe)

The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use , disposable device, provided nonsterile.

| 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

### 510(k) Number: K202710 Date of summary prepared: March 6, 2021

#### Submission Sponsor 1.

| Applicant Name | Wanxinda(Guangzhou)Technology Product Co.,Ltd. |
|----------------|--------------------------------------------------------------------------------------------------|
| Address | Ling Xi Road, Accessory Section 2, Automobile Zone, Huadu District, Guangzhou, Guangdong, China. |
| Contact person | Zeng Xueping |
| Phone | 86-020-61816666 |

#### 2. Submission correspondent

| Name | Shenzhen Joyantech Consulting Co., Ltd |
|----------------|--------------------------------------------------------------------------------|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District, Shenzhen |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Joyce Yang |
| Email | [e-mail] |

#### 3. Device Identification

| Type of 510(k) submission: | Traditional |
|----------------------------|------------------------------|
| Trade Name: | Disposable Medical Face Mask |
| Model: | WXDKZ0001, WXDKZ0006 |
| Classification name: | Mask, Surgical |
| Common name: | Surgical face mask |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |

#### Legally Marketed Predicate Device 4.

| Trade Name | Surgical Face Mask |
|-------------------|------------------------------|
| Regulation number | 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K133070 |
| Product Code | FXX |
| Manufacturer | BH Medical Products Co.,Ltd. |

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#### Device Description 5.

The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Disposable Medical Face Masks are manufactured with three layers, 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 elastic ear loops are not made with natural rubber latex.

The nose piece 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 with steel wire.

The proposed devices are sold non-sterile and are intended to be single use, disposable devices.

### 6. Intended Use/ Indications for Use

The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use ,disposable device, provided non-sterile.

| Comparison<br>item | Subject Device<br>(K202710) | Predicate Device<br>(K133070) | Comments |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Product<br>Code | FXX | FXX | Same |
| Regulation<br>Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classificatio<br>n | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intended<br>use &<br>Indication<br>s for Use | The Disposable Medical<br>Face 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.<br>These masks are intended<br>for use in infection control | The Disposable Surgical<br>Masks are intended to be<br>worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body<br>fluids and particulate<br>material. These face<br>mask are intended for use | Same |
| Comparison<br>item | Subject Device<br>(K202710) | Predicate Device<br>(K133070) | Comments |
| | practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single use ,disposable<br>device, provided non-sterile. | in infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single<br>use ,disposable device,<br>provided non-sterile. | |
| Design<br>feature | Ear-loop | Ear-loop, Tie-on | Similar<br>Issue 1 |
| Usage | Single use | Single use | Same |
| Color | White, Blue | Blue, Green | Similar<br>Issue 2 |
| Size | Width: $175mm \pm 5%$<br>Length: $95mm \pm 5%$ | Width: $6.5" +/-0.25"$<br>Length: $3.5" +/-0.25"$<br>$4.2" +/-0.25"$ | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: polypropylene<br>non-woven | Outer layer: Spun-bond<br>polypropylene | Same |
| | Middle layer: Melt blown<br>fabric | Middle layer: Melt blown<br>polypropylene | Same |
| | Inner layer: polypropylene<br>non-woven | Inner layer:Spun-bond<br>polypropylene | Same |
| | Nose piece: PP+Steel wire | Nose piece: Aluminum<br>wire | Similar<br>Issue 3 |
| | Ear-loops: Spandex | Ear-loops:Polyester | Similar<br>Issue 4 |
| ASTM F<br>2100 Level | Level 1 | Level 1, Level 2, Level 3 | Similar<br>Issue 5 |
| Fluid<br>Resistance<br>Performance<br>ASTM F<br>1862-13 | Meet the ASTM F2100<br>Requirements for Level 1<br>Classification | Meet the ASTM F2100<br>Requirements for Level 1,<br>Level 2, Level 3<br>Classification | Similar<br>Issue 5 |
| | | | |
| | | | |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F | Meet the ASTM F2100<br>Requirements for Level 1<br>Classification | Meet the ASTM F2100<br>Requirements for Level 1,<br>Level 2, Level 3 | Similar<br>Issue 5 |
| | | | |
| | | | |
| Comparison<br>item | Subject Device<br>(K202710) | Predicate Device<br>(K133070) | Comments |
| 2299 | | Classification | |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F<br>2101 | Meet the ASTM F2100<br>Requirements for Level 1<br>Classification | Meet the ASTM F2100<br>Requirements for Level 1,<br>Level 2, Level 3<br>Classification | Similar<br>Issue 5 |
| Differential<br>Pressure<br>(Delta P) EN<br>14683:2019+<br>AC : 2019 | Meet the ASTM F2100<br>Requirements for Level 1<br>Classification | Meet the ASTM F2100<br>Requirements for Level 1,<br>Level 2, Level 3<br>Classification | Similar<br>Issue 5 |
| Flammability<br>16CFR 1610 | 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 Non irritating | Same |
| Sensitization | Comply with ISO 10993-10<br>Non sensitizing | Comply with ISO 10993-<br>10 Non sensitizing | Same |

### 7. Technological characteristics comparison

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Issue 1: Design differences do not introduce different questions of safety and effectiveness.

Issue 2: The color master batch of proposed device outer layer is different from the predicate device. This difference will not affect the performance of the mask. Moreover, the proposed product has been tested for biocompatibility and has no potential toxicity or irritation.

Issue 3: The nose piece of the proposed device is made polypropylene with steel wire, which of the predicate device is made by Malleable aluminum wire. The Nose piece is between the inner and outer layers of the mask, which does not contact with the human body directly when used. Moreover, the whole product has been tested for biocompatibility, and the test results confirm that they have good biocompatibility, these differences do not introduce different questions of safety and effectiveness.

lssue 4: The Ear-loops of the proposed device are made by spandex, which of the predicate device is made by polyester. The major chemical composition of the spandex is segmented polyurethane-urea, which is similar to polyester. In addition, the proposed devices have been tested for biocompatibility, and the test results confirm that they have good biocompatibility, these differences do not introduce different questions of safety and effectiveness.

Issue 5: The level of the proposed device is covered by the predicate device.

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## 8. Summary of Non-clinical Testing

Disposable Medical Face Mask conforms to the following standards:

ASTM F 2100-19, Standard Specification for Performance of Materials Use in Medical Face Masks.

ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.

### Bench testing

The bench testing of Disposable Medical Face Mask include the following tests:

| *Fluid Resistance Performance: | Pass at 80 mmHg |
|-------------------------------------|------------------|
| *Particulate Filtration Efficiency: | 99.8% |
| *Bacterial Filtration Efficiency: | 99.8% |
| *Differential Pressure: | < 5.0 mm H2O/cm² |
| *Flammability: | Class 1 |

### Biocompatibility testing

According to ISO 10993-1:2009, the contact category for the subject device is Limited exposure category A, for devices whose cumulative single, multiple or repeated use or contact is up to 24 hours. The following tests for the subject device were conducted to demonstrate that the subject device conforms to ISO 10993-1:2009 and is biocompatible for its intended use:

- 1) In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity,
- 2) Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- 3) Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

### 9. Brief discussion of clinical tests

No clinical tests were performed.

## 10. Conclusions

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission K202710, the Disposable Medical Face Mask models WXDKZ001 and WXDKZ006 are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K133070.