Wilson Tech Disposable Medical Face Mask

K210184 · Wilson Tech (International) Limited · FXX · Sep 14, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210184
• Device Name: Wilson Tech Disposable Medical Face Mask
• Applicant: Wilson Tech (International) Limited
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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

Device Story

Disposable, flat-pleated, three-layer surgical face mask; outer/inner layers spun-bond polypropylene; middle layer melt-blown polypropylene filter; includes ear loops and malleable galvanized iron nose piece coated with polyethylene. Used in clinical settings for infection control; worn by healthcare personnel and patients to provide barrier protection against blood, body fluids, and particulates. Device is single-use and non-sterile.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19, ASTM F1862 (fluid resistance at 160 mmHg), ASTM F2299 (PFE >99.28%), ASTM F2101 (BFE >99.3%), MIL-M-36954C (Delta P <4.9 mmH2O/cm²), and 16 CFR Part 1610 (Class 1 flammability). Biocompatibility confirmed via ISO 10993-5 and ISO 10993-10 (non-cytotoxic, non-irritating, non-sensitizing).

Technological Characteristics

Three-layer construction: spun-bond polypropylene (outer/inner), melt-blown polypropylene (middle). Dimensions: 175mm x 95mm. Nose piece: polyethylene-coated galvanized iron. Ear loops: 11% Spandex, 13% Polyester, 76% Nylon. Meets ASTM F2100 Level 3 barrier specifications. Non-sterile, single-use.

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 settings.

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

• DemeMASK Surgical Mask (K201479)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2021

Wilson Tech (International) Limited % Julie Chen RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China

Re: K210184

Trade/Device Name: Wilson Tech Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 02, 2021 Received: September 07, 2021

Dear Julie Chen:

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 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,

For Clarence W. Murray, III, Ph.D. 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K210184

Device Name

Wilson Tech Disposable Medical Face Mask

Indications for Use (Describe)

Wilson Tech Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. Wilson Tech Disposable Medical Face Mask is single use, disposable device, provided non-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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#### 510k Summary - K210184

#### L SUBMITTER:

Wilson Tech (International) Limited 7/F, JOY Fat FACTORY BUILDING, 483 F-G CASTLE PEAK ROAD, KOWLOON, HONGKONG Contact Person: HO HANG TERRY TING Title: Managing Director Tel: [phone] Email: terry.ting(@wilson-acc.com

Submission Correspondent: Julie Chen, RA Manager Shanghai Mind-Link Business Consulting Co; Ltd., Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai 200040 CHN Email: [e-mail] Tel:[phone]

Summary prepared: September 14, 2021

#### II. DEVICE

Name of Device: Wilson Tech Disposable Medical Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX

#### III. PREDICATE DEVICE

Primary predicate device: DemeMASK Surgical Mask (K201479)

#### IV. DEVICE DESCRIPTION

Wilson Tech Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of galvanized iron wire coated with polyethylene to provide a firm fit over the nose.

#### V. AVAILABLE MODELS

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Wilson Tech Disposable Medical Face Mask contains only one model which is a blue mask, barrier protection level 3, size 175mm*95mm and ear loop type.

### VI. INDICATIONS FOR USE

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

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE

Wilson Tech Disposable Medical Face Masks are compared with the predicate device (DemeMASK Surgical Mask(K201479)). The results are shown below in the Technological Characteristics Comparison Table:

| DEVICE | Subject Device<br>Wilson Tech<br>Disposable Medical Face Mask (K201479) | Primary Predicate Device<br>DemeMASK Surgical Mask | Comparison |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Wilson Tech Disposable Medical Face Mask is intended to be<br>worn to protect both the patient<br>and healthcare personnel from<br>transfer of microorganisms, body fluids and particulate material.<br>Wilson Tech Disposable Medical Face Mask is intended for use in<br>infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. Wilson<br>Tech Disposable Medical Face<br>Mask is single use, disposable<br>device, provided non-sterile. | The surgical face masks are<br>intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids,<br>and particulate material. These<br>face masks are intended for use<br>in infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a<br>single-use, disposable device,<br>provided non-sterile. | Same |
| Classification<br>Product Code | FXX | FXX | Same |
| Ear Loop Model | Ear Loops | Ear Loops | Same |
| | Materials | | |
| Outer<br>Facing<br>Layer | 25gsm SS (spunbond -<br>spunbond) Nonwoven fabric | Spunbond polypropylene | Similar |
| Middle Layer | 25gsm meltblown Nonwoven<br>fabric | Meltblown polypropylene filter | Similar |
| Inner<br>Facing<br>Layer | 25gsm SS (spunbond -<br>spunbond) Nonwoven fabric | Spunbond polypropylene | Similar |
| Nose Piece | Galvanized iron wire coated with polyethylene | Galvanized wire coated with polyethylene | Similar |
| Ear Loops | 11% Spandex, 13% Polyester,<br>76% Nylon | Spandex and Nylon - Not made<br>from natural rubber latex | Similar |
| | Design Features | | |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple Layers | 3 Layers | 3 Layers | Same |
| Single Use | Single use | Single use | Same |
| | Sterility | | |
| Sterile | Non-sterile | Non-sterile | Same |
| | Dimension | | |
| Length Width | Length:175mm±5mm<br>Width:95mm±5mm | Length:17.5cm±1cm<br>Width: 9.5 cm±1 cm | Same |
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3 | | | |
| Fluid Resistance<br>ASTM F1862 | Pass at 160mmHg | Pass at 160 mmHg<br>(Level 3 Fluid Resistance) | Same |
| Particulate<br>Filtration Efficiency<br>(PFE)<br>ASTM F2299 | Pass at >98% | Pass at ≥99% | Same |
| Bacterial Filtration<br>Efficiency (BFE)<br>ASTM F2101 | Pass at >98% | Pass at ≥99% | Same |
| Differential<br>Pressure (Delta P)<br>MIL-M-36954C | Pass at <6 mmH2O/cm² | Average 3.6 mmH2O/cm² | Same |
| Flammability<br>16CFRPART 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Same |
| Biocompatibility | | | |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same |
| Irritation | Non-irritating | Non-irritating | Same |
| Sensitization | Non-sensitizing | Non-sensitizing | Same |

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#### VIII. PERFORMANCE DATA

#### Non-Clinical Performance Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Disposable Surgical Masks complies with the following standards:

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- ASTM F2100-19 Standard Specification for Performance of Materials Used ● in Medical Face Masks
- ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to . Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- . ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101 Standard Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- MIL-M- 36954C Military Specification, Mask, Surgical, Disposable
- 16 CFR Part 1610 Standard for the Flammability of Clothing
- ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
- ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
- ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization

| Test Methodology | Purpose of the test | Acceptance criteria | Test Results |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------|
| Bacterial Filtration<br>Efficiency | The test was performed in<br>accordance with ASTM F2101: 2019<br>Standard Test Method for<br>Evaluating the Bacterial Filtration<br>Efficiency (BFE) of Medical Face<br>Mask Materials, Using a Biological<br>Aerosol of Staphylococcus aureus to<br>determine the bacterial filtration<br>efficiency(BFE) of the test article | Level 3: ≥98% | 32/32 Passed at ≥99.3% |
| Particulate Filtration<br>Efficiency | The test was performed in<br>accordance with ASTM F2299<br>Standard Test Method for Determining<br>the Initial Efficiency of Material Used<br>in medical Face Masks to Penetration<br>by Particulates using Latex Spheres to<br>determine the particle filtration<br>efficiency (PFE) of the test article | Level 3: ≥98% | 32/32 Passed at ≥99.28% |
| Differentail Pressure<br>(delta-P) | The test was performed in<br>accordance with MIL-M- 36954C<br>Military Specification, Mask, Surgical,<br>Disposable | <6.0 mmH2O/cm² | 32/32 Passed at <4.9 mmH2O/cm² |

#### Non-clinical Testing Summary:

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| Resistance to<br>penetration by synthetic<br>blood, minimum<br>pressure in mm Hg for<br>pass result | The test was performed in<br>accordance with ASTM<br>F1862/F1862M Standard Test Method<br>for Resistance of Medical Face Masks<br>to Penetration by Synthetic Blood<br>(HorizontalProjection of Fixed Volume<br>at a Known Velocity) to evaluate the<br>effectiveness of the test sample from<br>possible exposure to blood and other<br>body fluids. | Level 3:<br>No penetration at<br>160 mmHg | 32/32 Passed at160mmHg |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------|
| Flammability | Level 3: No penetration at 160 mmHg | Class 1 | 32/32 Passed Class 1<br>requirement |

### Biocompatibility Testing Summary:

| Test Methodology | Purpose of the test | Acceptance criteria | Test Results |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------|
| In vitro Cytotoxicity<br>test | The purpose of the<br>biocompatibility testing is to<br>demonstrate the biocompatibility<br>of the subject device. | Non-Cytotoxic | Pass<br>Under the conditions of<br>the study, the device is<br>non-cytotoxic |
| Skin sensitization Test | | Non-Sensitizing | Pass<br>Under the conditions of<br>the study, the device is<br>non-sensitizing |
| Skin Irritation Test | | Non-Irritating | Pass<br>Under the conditions of<br>the study, the device is<br>non-irritating |

# Clinical Test Conclusion

No clinical study is included in this submission.

# IX. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device, Wilson Tech Disposable Medical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device DemeMASK Surgical Mask(K201479).