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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically the Wilson Tech Disposable Medical Face Mask. It details the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a detailed table comparing the subject device (Wilson Tech Disposable Medical Face Mask) with the primary predicate device (DemeMASK Surgical Mask - K201479). The key acceptance criteria are based on surgical mask performance standards, primarily ASTM F2100 Level 3.

Test Methodology	Purpose of the test	Acceptance criteria	Test Results (Wilson Tech Disposable Medical Face Mask)
Bacterial Filtration Efficiency (BFE)	Performed in accordance with ASTM F2101 to determine the bacterial filtration efficiency using a biological aerosol of Staphylococcus aureus.	Level 3: ≥98%	32/32 Passed at ≥99.3%
Particulate Filtration Efficiency (PFE)	Performed in accordance with ASTM F2299 to determine the particle filtration efficiency using latex spheres.	Level 3: ≥98%	32/32 Passed at ≥99.28%
Differential Pressure (delta-P)	Performed in accordance with MIL-M-36954C. Measures the breathability of the mask.	<6.0 mmH2O/cm²	32/32 Passed at <4.9 mmH2O/cm²
Resistance to penetration by synthetic blood	Performed in accordance with ASTM F1862/F1862M to evaluate the effectiveness of the sample from possible exposure to blood and other body fluids.	Level 3: No penetration at 160 mmHg	32/32 Passed at 160mmHg
Flammability	Evaluates the flammability of the material.	Class 1	32/32 Passed Class 1 requirement
Biocompatibility Tests
In vitro Cytotoxicity test	Purpose is to demonstrate the biocompatibility of the subject device.	Non-Cytotoxic	Pass (device is non-cytotoxic)
Skin sensitization Test		Non-Sensitizing	Pass (device is non-sensitizing)
Skin Irritation Test		Non-Irritating	Pass (device is non-irritating)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for performance tests: For the performance tests (BFE, PFE, Differential Pressure, Resistance to synthetic blood, Flammability), the test results state "32/32 Passed," indicating that 32 samples were tested for each of these criteria.
Data Provenance: The document does not explicitly state the country of origin for the test data. However, the submitter is "Wilson Tech (International) Limited" based in Hong Kong, and the submission correspondent is in Shanghai, China. The testing was non-clinical. The information is presented as a retrospective summary of tests already conducted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This section is not applicable as the document describes physical and chemical performance tests for a medical face mask, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for these tests are the established ASTM and MIL standards.

4. Adjudication Method for the Test Set:

This section is not applicable as the tests are objective, laboratory-based physical and chemical performance evaluations. There is no human adjudication involved in determining "ground truth" for these types of tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) where human readers interpret results, sometimes with AI assistance. The Wilson Tech Disposable Medical Face Mask is a physical barrier device, and its safety and effectiveness are assessed through its material properties and performance against established standards, not human interpretation of cases.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI. The performance tests are for the physical mask itself.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on established industry standards and test methodologies (e.g., ASTM F2101, ASTM F2299, MIL-M-36954C, ASTM F1862, 16 CFR Part 1610, ISO10993 series for biocompatibility). These standards define the acceptable performance thresholds (acceptance criteria) for medical face masks.

8. The Sample Size for the Training Set:

This section is not applicable. The device is not an AI or machine learning model, so there is no "training set." The tests described are for the physical product.

9. How the Ground Truth for the Training Set was Established:

This section is not applicable as there is no training set for this type of device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: 852-23125136 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: Julie.chen@mind-link.net Tel:+86 13918045781

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

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 DeviceWilson TechDisposable Medical Face Mask (K201479)	Primary Predicate DeviceDemeMASK Surgical Mask	Comparison
Intended Use	Wilson Tech Disposable Medical Face Mask is intended to beworn to protect both the patientand healthcare personnel fromtransfer of microorganisms, body fluids and particulate material.Wilson Tech Disposable Medical Face Mask is intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. WilsonTech Disposable Medical FaceMask is single use, disposabledevice, provided non-sterile.	The surgical face masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Theseface masks are intended for usein infection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile.	Same
ClassificationProduct Code	FXX	FXX	Same
Ear Loop Model	Ear Loops	Ear Loops	Same
	Materials
OuterFacingLayer	25gsm SS (spunbond -spunbond) Nonwoven fabric	Spunbond polypropylene	Similar
Middle Layer	25gsm meltblown Nonwovenfabric	Meltblown polypropylene filter	Similar
InnerFacingLayer	25gsm SS (spunbond -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,76% Nylon	Spandex and Nylon - Not madefrom 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±5mmWidth:95mm±5mm	Length:17.5cm±1cmWidth: 9.5 cm±1 cm	Same
Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3
Fluid ResistanceASTM F1862	Pass at 160mmHg	Pass at 160 mmHg(Level 3 Fluid Resistance)	Same
ParticulateFiltration Efficiency(PFE)ASTM F2299	Pass at >98%	Pass at ≥99%	Same
Bacterial FiltrationEfficiency (BFE)ASTM F2101	Pass at >98%	Pass at ≥99%	Same
DifferentialPressure (Delta P)MIL-M-36954C	Pass at <6 mmH2O/cm²	Average 3.6 mmH2O/cm²	Same
Flammability16CFRPART 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 FiltrationEfficiency	The test was performed inaccordance with ASTM F2101: 2019Standard Test Method forEvaluating the Bacterial FiltrationEfficiency (BFE) of Medical FaceMask Materials, Using a BiologicalAerosol of Staphylococcus aureus todetermine the bacterial filtrationefficiency(BFE) of the test article	Level 3: ≥98%	32/32 Passed at ≥99.3%
Particulate FiltrationEfficiency	The test was performed inaccordance with ASTM F2299Standard Test Method for Determiningthe Initial Efficiency of Material Usedin medical Face Masks to Penetrationby Particulates using Latex Spheres todetermine the particle filtrationefficiency (PFE) of the test article	Level 3: ≥98%	32/32 Passed at ≥99.28%
Differentail Pressure(delta-P)	The test was performed inaccordance with MIL-M- 36954CMilitary Specification, Mask, Surgical,Disposable	<6.0 mmH2O/cm²	32/32 Passed at <4.9 mmH2O/cm²

Non-clinical Testing Summary:

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Resistance topenetration by syntheticblood, minimumpressure in mm Hg forpass result	The test was performed inaccordance with ASTMF1862/F1862M Standard Test Methodfor Resistance of Medical Face Masksto Penetration by Synthetic Blood(HorizontalProjection of Fixed Volumeat a Known Velocity) to evaluate theeffectiveness of the test sample frompossible exposure to blood and otherbody fluids.	Level 3:No penetration at160 mmHg	32/32 Passed at160mmHg
Flammability	Level 3: No penetration at 160 mmHg	Class 1	32/32 Passed Class 1requirement

Biocompatibility Testing Summary:

Test Methodology	Purpose of the test	Acceptance criteria	Test Results
In vitro Cytotoxicitytest	The purpose of thebiocompatibility testing is todemonstrate the biocompatibilityof the subject device.	Non-Cytotoxic	PassUnder the conditions ofthe study, the device isnon-cytotoxic
Skin sensitization Test		Non-Sensitizing	PassUnder the conditions ofthe study, the device isnon-sensitizing
Skin Irritation Test		Non-Irritating	PassUnder the conditions ofthe study, the device isnon-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).

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.