Disposable medical mask
Device Facts
| Record ID | K203388 |
|---|---|
| Device Name | Disposable medical mask |
| Applicant | Everwin Toys (Dongguan)., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Jun 4, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Disposable medical masks are intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
Device Story
Disposable medical mask (WSKZ-001) is a flat-pleated, single-use surgical mask; intended for professional healthcare environments. Construction consists of three layers: inner and outer spunbond polypropylene; middle melt-blown polypropylene layer. Features include two ammonium nylon elastic ear loops (ultrasonically welded) and a polypropylene/iron nose clip for facial fit. Device is non-sterile; dimensions 175mm x 95mm. Healthcare workers wear the mask to provide a physical barrier against microorganisms, bodily fluids, and particulates. Performance meets ASTM F2100 Level 1 requirements.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100-19 standards: Bacterial Filtration Efficiency (≥99.2%), Differential Pressure (<4.0 mm H2O/cm²), Particulate Filtration Efficiency (≥96.1%), Fluid Resistance (80 mmHg), and Flammability (Class 1). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-5 and ISO 10993-10 confirmed non-cytotoxic, non-sensitizing, and non-irritating results.
Technological Characteristics
Three-layer mask: spunbond polypropylene (inner/outer), melt-blown polypropylene (middle). Nose clip: polypropylene/iron. Ear loops: ammonium nylon. Dimensions: 175mm x 95mm. Non-sterile. ASTM F2100 Level 1 performance. Biocompatibility per ISO 10993-1, 5, and 10.
Indications for Use
Indicated for use by healthcare workers during procedures to protect patients and workers against transfer of microorganisms, bodily fluids, and particulate materials. Single-use, non-sterile.
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
- Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) (K153409)
Submission Summary (Full Text)
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June 4, 2021
Everwin Toys (Dongguan)., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K203388
Trade/Device Name: Disposable medical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 25, 2021 Received: May 5, 2021
Dear Cassie Lee:
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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence Murray III, Ph.D. 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) K203388
Device Name Disposable medical mask
Indications for Use (Describe)
The Disposable medical masks are intended for use by healthcare workers to procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
Model: WSKZ-001 Color : Blue
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary for K203388
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
### 1. Date of the summary prepared: June 04, 2021
#### 2. Submitter's Information
510(k) Owner's Name: EVERWIN TOYS (DONGGUAN)., LTD. Establishment Registration Number: 3012360847 Address: Xiekeng Village,Qingxi Town ,Dongguan City ,Guangdong Province , China Post Code : 523000 Contact name: Huang Zibin Tel: +86 0769-87314418-6118 Phone: +86 13790595177 E-mail: zhaogang@wahshing.com
# Application Correspondent :
Contact Person : Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel : +86 20 8266 2446 Email : regulatory@glomed-info.com
#### 3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable medical mask Model: WSKZ-001 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
#### Predicate Device Information 4.
Sponsor: Protect U Guard, LLC Device Name: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Model: P10031, P10032, P10033, P10041, P10042, P10043 Classification Name: Mask, Surgical 510(K) Number: K153409 Review Panel: General Hospital Product Code: FXX Requlation Number: 21 CFR 878.4040 Regulation Class: II
### 5. Indications for Use
The Disposable medical masks are intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
Model: WSKZ-001 Color: Blue
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The Disposable medical mask is flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clip design for fitting the facemask around the nose. The Disposable medical mask is only one model: WSKZ-001 and the color is blue.
The Disposable medical mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue, CAS number: 147-14-8), and the middle layer is made of melt blown fabric.
Ear loops, which is held to cover the users' mouth and nose by two Ammonium nylon elastic bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex.
The nose clip contained in the Disposable medical mask is in the middle layer of Disposable medical mask to allow the user to fit the Disposable mask around their noses, which is made of Polypropylene and metallic iron.
The Disposable medical mask is sold non-sterile and is intended to be single use, and the intended environment is professional healthcare facility environment. The shelf life of each Disposable medical mask is 2 years.
The dimensions of each Disposable medical mask are length 175mm and width 95mm. The dimension of nose clip is length 100mm, and the ear loop is length 170mm.
### 7. Comparison of Technological Characteristics
The following table identifies technological characteristics shared between the subject device and Predicate:
| Elements of<br>Comparison | Subject Device (K203388) | Predicate Device (K153409) | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | EVERWIN TOYS (DONGGUAN)., LTD. | Protect U Guard, LLC | -- |
| 510 (k) | K203388 | K153409 | -- |
| Trade Name | Disposable medical mask | Protect U Guard Earloop and Tie-<br>On Mask (Blue, White or Green) | -- |
| Model | WSKZ-001 | Earloop Models: Blue (P10031),<br>White (P10032), or Green<br>(P10033)<br>Tie-On Models: Blue (P10041),<br>White (P10042), or Green<br>(P10043) | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX<br>(21 CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Same |
| Intended use | The Disposable medical masks are<br>intended for use by healthcare<br>workers during procedures to protect<br>both patients and healthcare workers<br>against transfer of microorganisms,<br>bodily fluids, and particulate<br>materials. This device is single-use<br>and provided non-sterile. | Earloop Mask and Tie-On Mask<br>is intended for use by healthcare<br>workers during procedures to<br>protect both patients and<br>healthcare workers against<br>transfer of microorganisms,<br>bodily fluids, and airborne<br>particles. This device is single-<br>use and provided non-sterile.<br>Earloop Models: Blue (P10031),<br>White (P10032), or Green<br>(P10033)<br>Tie-On Models: Blue (P10041),<br>White (P10042), or Green<br>(P10043)<br>Over-The-Counter Use | Similar |
| Material | | | |
| Elements of<br>Comparison | Subject Device (K203388) | Predicate Device (K153409) | Comparison |
| Outer facing<br>layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle layer | Melt blown polypropylene | Melt blown polypropylene | Same |
| Inner facing<br>layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose clip | Polypropylene and metallic iron | Aluminum strip | Similar<br>Note 1 |
| Ear loops | Ammonium nylon elastic | Urethane elastic fiber | Similar<br>Note 1 |
| Design<br>features | Color: Blue<br>Ear loops | Color: Blue, White,<br>Green Ear loops | Same |
| Dimension | 17.5cm x 9.5 cm | 17.7cm x 9.5 cm | Similar<br>Note 1 |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance<br>Testing | Level 1 | Level 1 | Same |
| Fluid<br>Resistance<br>Performance | Pass at 80 mmHg | Pass at 80 mmHg | Same |
| Particulate<br>Filtration<br>Efficiency | ≥96.1% | 99.18% at 0.1 micron | Similar<br>Note 2 |
| Bacterial<br>Filtration<br>Efficiency | ≥99.2% | 99.17% | Similar<br>Note 2 |
| Differential<br>Pressure | <4.0 mm H2O/cm2 | 3.79 mm H2O/cm² | Similar<br>Note 2 |
| Flammability | Class 1 | Class 1 | Same |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the study, the<br>subject device extract was determined<br>to be non-cytotoxic. | Under the conditions of the<br>study, the subject device<br>extract was<br>determined to be non-cytotoxic. | Same |
| Irritation | Under the conditions of the study, the<br>subject device non-polar and polar<br>extracts were determined to be non-<br>irritating. | Under the conditions of the<br>study, the subject device non-<br>polar and polar extracts were<br>determined to be non-irritating. | Same |
| Sensitization | Under the conditions of the study, the<br>subject device non-polar and polar<br>extracts were determined to be non-<br>sensitizing. | Under the conditions of the<br>study, the subject device non-<br>polar and polar extracts were<br>determined to be non-<br>sensitizing. | Same |
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# Comparison in Detail(s):
# Note 1:
Although the "Ear loops", "Nose clip" and "Dimension" of subject device is a little different from predicate device, they all meet the requirements of essential performance standard ASTM F2100 and ISO 10993 series. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
# Note 2:
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is a little different from predicate device, they all meet the level 1 requirements of essential performance standard ASTM F2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
#### 8. Non-Clinical Performance Testing Summary:
| Test item<br>(Performance<br>Level 1) | Test method | Pass<br>criteria | Test results |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------------------------------------------|
| Bacterial filtration<br>efficiency | ASTM F2101-14 Standard<br>Test Method for Evaluating the<br>Bacterial Filtration Efficiency<br>(BFE) of Medical Face Mask<br>Materials, Using a Biological<br>Aerosol of Staphylococcus<br>aureus according to ASTM<br>F2100:2019 | ≥ 98% | 32/32 Passed at ≥99.2%<br>/ Pass |
| Differential<br>pressure (Delta-<br>P) | EN 14683: 2019, Annex C<br>Medical face masks -<br>Requirements and test<br>methods according to ASTM<br>F2100:2019 | <5.0 mm<br>H2O/cm² | 32/32 Passed at <4.0<br>mm H2O/cm²/ Pass |
| Particulate<br>Filtration<br>Efficiency | ASTM F2299-03 Standard<br>Test Method for Determining<br>the Initial Efficiency of<br>Materials Used in Medical<br>Face Masks to Penetration by<br>Particulates Using Latex<br>Spheres according to ASTM<br>F2100:2019 | ≥ 95% | 32/32 Passed at ≥96.1%<br>/ Pass |
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| Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in<br>mmHg<br>for pass result | ASTM F1862/F1862M-17<br>Standard Test Method for<br>Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume at<br>a Known Velocity) according<br>to ASTM F2100:2019 | Fluid<br>resistant<br>claimed<br>at 80<br>mmHg | 32/32 Passed at 80<br>mmHg/ Pass |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------|
| Flame spread | 16 CFR Part 1610 Standard<br>for the Flammability of<br>Clothing according to ASTM<br>F2100:2019 | Class 1 | 32/32 Passed ≥3<br>Seconds burn<br>Time-Class 1 / Pass |
# Biocompatibility Testing Summary:
According to ISO 10993-1: 2018, the nature of body contact for the subject device is the Surface Device category, Skin Contact, and duration of the contact is A-Limited (<24 h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
| Title of the test | Purpose of the test | The source of references (Test method) | Acceptance criteria | Test results |
|----------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------|
| In vitro Cytotoxicity Test | Under the research conditions, determine whether the target device extract is cytotoxic. | ISO 10993-5:2009<br>Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | Under the research conditions, determine whether the non-polar and polar extracts of the target device are sensitive. | ISO 10993-10:2010<br>Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | Under the research conditions, determine whether the non-polar and polar extracts of the target device are irritating. | ISO 10993-10:2010<br>Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
# 9. Summary of Clinical Performance Test
No clinical study is included in this submission.
# 10. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device, Disposable medical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K153409, Protect U Guard Earloop and Tie-On Mask (Blue, White, or Green).
