The Procedure mask/Surgical 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. This is a single-use, disposable device, provided non-sterile.

Device Description

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 3 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

AI/ML Overview

This document is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). The information provided demonstrates that the device meets the acceptance criteria through non-clinical testing.

Here's the breakdown of your requested information:

1. A table of acceptance criteria and the reported device performance

Test Methodology	Acceptance Criteria (Level 3 ASTM F2100-19)	Reported Device Performance (Proposed Device)
Resistance to Penetration by Synthetic blood	No penetration at 160 mmHg	Pass at 160mmHg
Particulate Filtration Efficiency (PFE)	≥98%	Blue mask: Pass at 99.75 % Black mask: Pass at 99.03 %
Bacterial Filtration Efficiency (BFE)	≥98%	Blue mask: Pass at 99.87 % Black mask: Pass at 98.90 %
Differential Pressure	<6.0 mmH2O/cm²	Blue mask: Pass at 4.8 mmH2O/cm² Black mask: Pass at 3.7 mmH2O/cm²
Flammability	Class 1	Class 1
Cytotoxicity	Viability ≥70% of the blank	Viability ≥70% of the blank (Non-cytotoxic)
Sensitization	Non-sensitizing	Non-sensitizing
Irritation	Non-irritating	Non-irritating

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each non-clinical test. However, it indicates that the tests were performed in accordance with the referenced standards (e.g., ASTM F1862/F1862M, ASTM F2299/F2299M-03, ASTM F2101, EN 14683, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards typically define appropriate sample sizes for such tests.

The provenance of the data is that the tests were performed on the proposed device by Winner Medical Co., Ltd. The company is located in Shenzhen, Guangdong, China. The data is prospective, generated specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a non-clinical study for a physical device (surgical mask) based on standardized test methods for material performance and biocompatibility. Therefore, the "ground truth" is defined by the established acceptance criteria within those standards, as measured by laboratory testing. There are no "experts" in the sense of medical professionals establishing ground truth from observational data; rather, the expertise lies in the certified laboratories and personnel performing the standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for non-clinical performance testing of a physical device. The results are obtained through standardized laboratory measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the non-clinical tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (ASTM, EN, ISO, CFR) for medical face masks and biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. As noted above, there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 6, 2023

Winner Medical Co., Ltd. Mingni Liu Regulatory Affairs Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen Guangdong 518109 China

Re: K223232

Trade/Device Name: Procedure mask/Surgical mask/Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 8, 2023 Received: February 8, 2023

Dear Mingni Liu:

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.

Katherine D. Kavlock -S

for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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) K223232

Device Name

Procedure mask/Surgical mask/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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: __K223232

1. Date of Preparation: October 18, 2022
1. Sponsor Identification

Winner Medical Co., Ltd. Winner Industrial Park, No.660 Bulong Road, Longhua District, Shenzhen Guangdong, China 518109

Establishment Registration Number: 9616433

Contact Person: Mingni Liu Position: Regulatory Affairs Tel: +86-755-28138888-8822 Email: 2346@winnemedical.com

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3. Identification of Proposed Device

Trade Name: Procedure mask/Surgical mask/Face mask Common Name: Surgical Face Mask

Regulatory Information Classification Name: Mask, Surgical; Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040; Review Panel: General Hospital;

Indications for use:

The Procedure mask/Surgical mask/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. This is a single-use, disposable device, provided non-sterile.

Device Description:

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Product name	ASTMF2100-19level	Ear strap type	Size (cm)	Color	Layers	Sterilization
Proceduremask/Surgicalmask/Face mask	Level 3	Ear loop	17.5x9.5	Blue	3	Non-sterile
			17.5x9.5	Black
			14.5x9	Blue
			14.5x9	Black
		Tie-on	17.5x9.5	Blue

Table 1 Procedure mask/Surgical mask/Face mask Description

4. Identification of Predicate Device

510(k) Number: K220194 Product Name: Procedure mask/Surgical mask/Face mask

5. Summary of Non-Clinical Test

Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A ASTM F1862/F1862M: 2017 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/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
A ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
A EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization

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Test Methodology	Purpose	Acceptance Criteria	Result
Resistance toPenetration bySynthetic blood	The test was performed inaccordance with ASTMF1862/F1862M: 2017 Standard TestMethod for Resistance of MedicalFace Masks to Penetration bySynthetic Blood (HorizontalProjection of Fixed Volume at aKnown Velocity) to evaluate theeffectiveness of the test article frompossible exposure to blood and otherbody fluids.	Level 3: No penetration at160 mmHg	Level 3: Pass at160mmHg
ParticulateFiltrationEfficiency	The test was performed inaccordance with ASTMF2299/F2299M-03 (2017) StandardTest Method for Determining theInitial Efficiency of Material Usedin medical Face Masks toPenetration by Particulates usingLatex Spheres to determine theparticle filtration efficiency (PFE) ofthe test article.	Level 3: ≥98%	Blue mask:Pass at 99.75 %Black mask:Pass at 99.03 %
Bacterial FiltrationEfficiency	The test was performed inaccordance with ASTM F2101:2019 Standard 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%	Blue mask:Pass at 99.87 %Black mask:Pass at 98.90 %

DifferentialPressure	The test was performed inaccordance with EN14683:2019+AC: 2019 Annex CMedical face masks - Requirementsand test methods to determine thedifferential pressure of the testarticle.	Level 3:<6.0 mmH2O/cm2	Blue mask:Pass at 4.8mmH2O/cm2Black mask:Pass at 3.7mmH2O/cm2
Flammability	The test was performed inaccordance with 16 CFR Part 1610Standard for the Flammability ofClothing Textiles to evaluate theflammability of the test article.	Class 1	Class 1
Cytotoxicity	The test was performed inaccordance with ISO 10993-5 Thirdedition 2009-06-01 Biologicalevaluation of medical devices - Part5: Tests for in vitro cytotoxicity toevaluate the cytotoxicity of the testarticle.	The viability should be≥70% of the blank. Andthe 50% extract of the testsample should have at leastthe same or a higherviability than the 100%extract.	The viability was≥70% of theblank. And the50% extract of thetest sample had ahigher viabilitythan the 100%extract.Under theconditions of thestudy, theproposed devicewasnon-cytotoxic.
Sensitization	The test was performed inaccordance with ISO 10993-10Third Edition 2010-08-01Biological evaluation of medical	Non-sensitizing	Under theconditions of thestudy, theproposed device
	devices - Part 10: Tests for irritationand skin sensitization to evaluate thesensitization of the test article.		wasnon-sensitizing.
Irritation	The test was performed inaccordance with ISO 10993-10Third Edition 2010-08-01Biological evaluation of medicaldevices - Part 10: Tests for irritationand skin sensitization to evaluate theirritation of the test article.	Non-irritating	Under theconditions of thestudy, theproposed devicewas non-irritating.

Table 2 Summary of Performance Testing

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1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Technological Characteristics Comparison

ITEM	Proposed Device	Predicate DeviceK220194	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indications forUse	The Proceduremask/Surgicalmask is intendedto be worn toprotect both thepatient andhealthcarepersonnel fromtransfer ofmicroorganisms,body fluids, andparticulatematerial. Theseface masks are	The Procedure mask/Surgical mask is intended to beworn to protect both the patient and healthcarepersonnel from transfer of microorganisms, bodyfluids, and particulate material. These face masksare intended for use in infection control practices toreduce the potential exposure to blood and bodyfluids. This is a single-use, disposable device,provided non-sterile.	Same
	intended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids.This is asingle-use,disposable device,providednon-sterile.
Mask style	Flat pleated	Flat pleated		Same
Design feature	Ear loop / Tie-on	Ear loop / Tie-on		Same
Dimension	Ear loops:Body: 175 mm×95 mm, nose clip: 110mm,Ear-loop: 178mmBody: 145 mm×90 mm, nose clip: 85mm, Ear-loop: 145mm	Ear loops:Body: 175 mm×95 mm, nose clip: 110mm,Ear-loop: 178mmBody: 145 mm×90 mm, nose clip: 85mm, Ear-loop: 145mmTie-on:Body: 175 mm×95 mm, nose clip: 110mm,Ear-loop: 900mm		Same
	Tie-on:Body: 175 mm×95 mm, nose clip: 110mm,Ear-loop: 900mm
ASTM F2100Level	Level 3	Level 1	Level 2	Same
FluidResistance	Pass at 160mmHg	Pass at 80mmHg	Pass at 120 mmHg	Same
Particulatefiltrationefficiency	Blue mask:Pass at 99.87 %Black mask:Pass at 98.90 %	Blue mask:Pass at 96.05%Black mask:Pass at 96.03%	Blue mask:Pass at 98.78%Black mask:Pass at 98.75%	Different
Bacterialfiltration	Blue mask:Pass at 99.75%	Blue mask:Pass at 98.25%	Blue mask:Pass at 98.72%	Different

Table 3 Comparison of Procedure mask/Surgical mask

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efficiency		Black mask:Pass at 99.03 %	Black mask:Pass at 98.25%	Black mask:Pass at 98.73%
Differentialpressure		Blue mask:Pass at 4.8 mmH2O/cm²Black mask:Pass at 3.7 mmH2O/cm²	Blue mask:Pass at 3.5 mmH2O/cm²Black mask:Pass at 3.5 mmH2O/cm²	Blue mask:Pass at 3.5 mmH2O/cm²Black mask:Pass at 3.6 mmH2O/cm²	Different
	Flammability		Class 1	Class 1	Class 1	Same
Label/Labeling		Complied with 21 CFR part 801	Complied with 21 CFR part 801		Same
Materials
	Ear loopPolyester and spandex		Polyester and spandex
	Tie strings38g /m² polypropylene nonwoven		38 /m² polypropylene nonwoven
	Nose clipIron and polypropylene		Iron and polypropylene
	Outermaterial	35g/m² polypropylene nonwoven	Outermaterial25g/m² polypropylene nonwoven	30g/m² polypropylene nonwoven	Different
Maskbody	Middlematerial	33g/m² polypropylene melt-blown nonwoven	Middlematerial25g/m² polypropylene melt-blown nonwoven	30g/m² polypropylene melt-blown nonwoven
	Innermaterial	25g/m² polypropylene nonwoven	Innermaterial25g/m² polypropylene nonwoven	30g/m² polypropylene nonwoven
Colors		Blue; Black	Blue; Black		Same
Biocompatibility
Cytotoxicity		Under the conditions of the study, the proposed device	Under the conditions of the study, the proposed device was non-cytotoxic.		Same

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	wasnon-cytotoxic.
Sensitization	Undertheconditions of thestudy,theproposed devicewasnon-sensitizing.	Under the conditions of the study, the proposeddevice was non-sensitizing.	Same
Irritation	Undertheconditions of thestudy,theproposed devicewas non-irritating.	Under the conditions of the study, the proposeddevice was non-irritating.	Same
Sterilization
Method	Non-sterile	Non-sterile	Same

Different - Particulate efficiency

The test result for particulate filtration efficiency for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 3 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of proposed device.

Different - Bacterial filtration efficiency

The test result for bacterial filtration efficiency for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 3 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of proposed device.

Different - Differential pressure

The test result for differential pressure for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 3 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of proposed device.

Different - Materials

The material for the proposed device is the same as the predicate device, both of the proposed device and the predicate device are manufactured by Winner Medical. Level 2 and level 3 masks based on ASTM F2100-19 are made of the same material, except for the difference in the gram weight of the inner, outer and middle layer of the mask. The material of the tie on mask can be covered by the material of the ear loop mask. Therefore, biocompatibility tests were performed on level 2 ear loop blue and black masks, the results does not show any adverse effect. Thus, this difference in the gram weight will

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not affect the safety and effectiveness of the proposed device.

8. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K220194.

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.