Disposable Medical Face Mask
Device Facts
| Record ID | K202439 |
|---|---|
| Device Name | Disposable Medical Face Mask |
| Applicant | Hunan Eexi Technology & Service Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Mar 8, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
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 mask 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, flat face mask (model YX001) with ear-loops and malleable nose piece; worn over mouth and nose to provide barrier protection against microorganisms, body fluids, and particulates. Outer layer: spun-bond polypropylene; middle layer: melt-blown polypropylene filter; inner layer: spun-bond polypropylene. Nose piece: PE and steel wire. Ear-loops: elastic fiber (segmented polyurethane-urea). Device is non-sterile, single-use, and intended for infection control in clinical settings. Provides physical barrier to reduce exposure to blood and body fluids; performance meets ASTM F2100 Level 2 requirements.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100-19, ASTM F1862-13 (synthetic blood penetration at 120 mmHg), ASTM F2299 (99.9% PFE), ASTM F2101 (99.9% BFE), and EN 14683:2019 (Delta P 4.7 mmH2O/cm²). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Three-layer non-woven mask. Materials: Spun-bond polypropylene (outer/inner), melt-blown polypropylene (filter), PE+steel wire (nose piece), elastic fiber (ear-loops). Colorants: Copper phthalocyanine, Titanium dioxide. Performance: ASTM F2100 Level 2. Flammability: 16 CFR 1610 Class 1. Biocompatibility: ISO 10993-5/10 compliant. Non-sterile.
Indications for Use
Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material in infection control practices to reduce exposure to blood and body fluids.
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 Face Mask (K153496)
Submission Summary (Full Text)
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March 8, 2021
Hunan EEXI Technology & Service 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: K202439
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: January 18, 2021 Received: February 8, 2021
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 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 (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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K202439
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 mask 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: K202439
## Date of Summary prepared: March 4, 2021
#### 1. Submission Sponsor
| Applicant Name | Hunan EEXI Technology & Service Co.,Ltd. |
|----------------|----------------------------------------------------------------------------------------|
| Address | No. 6 North of Pingtou Road, Liuyang Hi-tech Industrial Development Zone, Hunan China. |
| Contact person | Zhang Xianliang |
| Phone | +0086-15874115252 |
#### 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 | joyce@cefda.com |
| | |
#### 3. Device Identification
| Type of 510(k) submission: | Traditional |
|----------------------------|------------------------------|
| Trade Name: | Disposable Medical Face Mask |
| Common name: | Surgical face mask |
| Model: | YX001 |
| Classification name: | Mask, Surgical |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |
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### 4. Legally Marketed Predicate Device
| Trade Name: | Disposable Medical Face Mask |
|--------------------|------------------------------------------|
| Regulation number: | 21 CFR 878.4040 |
| Regulation class: | II |
| Regulation name: | Surgical Apparel |
| 510(k) Number: | K153496 |
| Product Code: | FXX |
| Manufacturer: | Xiantao Rayxin Medical Products Co.,Ltd. |
#### 5. Device Description
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 outer layer is made of PPSB non-woven fabric, which the chemical composition is the mixture of Polypropylene and color master batch. Inner layer is made of Polyethylene, polypropylene and mixture of fiber finishes. And the middle layer is made of melt blown polypropylene filter.
The model of proposed device ,YX001, is held in place over the user's mouth and nose bu 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 Malleable aluminum wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices. The colorants used for mask are Copper phthalocyanine and Titanium dioxide.
#### 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 mask 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.
potential exposure to blood and body fluids.
#### 7. Technological characteristics comparison
The Disposable Medical Face Mask is compared with the predicate device Disposable Medical Face Mask(K153496). The product characteristics are shown as follow:
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| Comparison<br>item | Subject Device<br>(K202439) | Predicate Device<br>(K153496) | 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 mask 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<br>single use ,disposable<br>device, provided non-sterile. | The Disposable Surgical<br>Face Masks are intended<br>to be worn to protect both<br>the patient and healthcare<br>personnel from transfer of<br>microorganisms, body<br>fluids and particulate<br>material. These face mask<br>are intended for use in<br>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. | Same |
| Design<br>feature | Ear-loop | Ear-loop, Tie-on | Similar<br>Issue 1 |
| Usage | Single use | Single use | Same |
| Color | Blue | Blue | Same |
| Size | (175±10)mm×(95±10)mm | (17.5±1)cm×(9.5±1)cm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| | Outer layer: Spun-bond<br>polypropylene | Outer layer: Spun-bond<br>polypropylene | Same |
| | Middle layer: Melt blown<br>polypropylene filter | Middle layer: Melt blown<br>polypropylene filter | Same |
| Comparison<br>item | Subject Device<br>(K202439) | Predicate Device<br>(K153496) | Comments |
| Material | Inner layer: Spun-bond<br>polypropylene | Inner layer:Spun-bond<br>polypropylene | Same |
| | Nose piece: PE+ Steel wire | Nose piece: Malleable<br>aluminum wire | Different<br>Issue 2 |
| | Ear-loops: Elastic fiber | Ear-loops: Polyester | Similar<br>Issue 3 |
| ASTM F<br>2100 Level | Level 2 | Level 2 | Same |
| Fluid<br>Resistance<br>Performance<br>ASTM F<br>1862-13 | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Same |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F<br>2299 | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Same |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F<br>2101 | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Same |
| Differential<br>Pressure<br>(Delta P)<br>MIL-M-<br>36954C | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Meet the ASTM F2100<br>Requirements for Level 2<br>Classification | Same |
| 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 10993-10<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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lssue 1: Design differences do not introduce different questions of safety and effectiveness.
lssue 2 : The nose piece of the proposed device is made by PE+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.
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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.
Issue 3: The Ear-loops of the proposed device are made by elastic fiber, which of the predicate device is made by polyester. The major chemical composition of the elastic fiber is seqmented 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.
## 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:
- 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.
- 16 CFR 1610 Standard For The Flammability Of Clothing Textiles.
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for Development, validation, and routine control of a sterilization process for Medical devices
- 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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| Items | Purpose | Acceptance<br>criteria | Subject<br>device test<br>result<br>(K202439) | Predicate<br>device(K1<br>53496) |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------|--------------------------------------------|
| Resistance to<br>penetration by<br>synthetic<br>blood(ASTM<br>F1862) | This procedure was<br>performed to evaluate<br>surgical facemasks and<br>other types of protective<br>clothing materials designed<br>to protect against fluid<br>penetration. | Pass at<br>120<br>mmHg | Pass at<br>120 mmHg | Pass at<br>120 mmHg<br>Pass at<br>160 mmHg |
| Sub-micron<br>particulate<br>filtration<br>efficiency<br>( ASTMF2299<br>) | This procedure was<br>performed to evaluate the<br>non-viable particle filtration<br>efficiency (PFE) of the test<br>article. Monodispersed<br>polystyrene latex spheres<br>(PSL) were nebulized<br>(atomized), dried, and<br>passed through the test<br>article. | > 98% | 99.9% | > 98% |
| Bacterial<br>Filtration<br>Efficiency<br>(ASTM F2101) | The BFE test is performed<br>to determine the filtration<br>efficiency of test articles by<br>comparing the bacterial<br>control counts up stream of<br>the test article to the<br>bacterial counts<br>downstream. | > 98% | 99.9% | > 98% |
| Differential<br>Pressure<br>(EN<br>14683:2019) | The Delta P test is<br>performed to determine the<br>breathability of test articles<br>by measuring the<br>differential air pressure on<br>either side of the test article<br>using a manometer, at a<br>constant flow rate. | < 6.0<br>mmH2O/<br>cm² | 4.7mmH2O<br>/cm² | < 6.0<br>mmH2O/c<br>m² |
| Items | Purpose | Acceptance<br>criteria | Subject<br>device test<br>result<br>(K202439) | Predicate<br>device(K1<br>53496) |
| Flame spread(16<br>CFR 1610) | This procedure was<br>performed to evaluate the<br>flammability of plain surface<br>clothing textiles by<br>measuring the ease of<br>ignition and the speed of<br>flame spread. | Class 1 | Class 1 | Class 1 |
# Table 2: Performance Characteristic Comparison
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### Table 3: Biocompatibility Comparison
| Items | Subject device<br>(K202439) | Predicate device(K153496) |
|---------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Cytotoxicity | Under the conditions of the<br>study, the test article was found<br>to be non-cytotoxic | Under the conditions of the<br>study, the test article was found<br>to be non-cytotoxic |
| Irritation | Under the conditions of the<br>study, the test article was found<br>to be non-irritation | Under the conditions of the<br>study, the test article was found<br>to be non-irritation |
| Sensitization | Under the conditions of the<br>study, the test article was found<br>to be non-sensitizing | Under the conditions of the<br>study, the test article was found<br>to be non-sensitizing |
#### 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 K202439, the Disposable Medical Face Masks are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K153496.
