The Medical Disposable Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is 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 Description

The Medical Disposable Face Mask is blue color, single use, three-layer, flat-pleated mask with nose piece and ear loop. The blue colorant is polypropylene (PP) masterbatch. The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of polyester and spandex, not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum with polypropylene (PP) covering. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The medical face masks are available in two size specifications, 17.5×9.5cm, 14.5×9.5cm. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Medical Disposable Face Masks." It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document does not contain information about an AI/ML-driven medical device, but rather a standard medical device (face masks).

Therefore, the specific information requested about acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, or training sets is not applicable to this document. The document describes non-clinical performance testing for the physical properties and biological compatibility of face masks.

However, I can extract the acceptance criteria and reported performance for the face mask product, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance (for Face Masks)

Test Standard	Performance Criteria (Acceptance Criteria)	Reported Device Performance
Fluid Resistance ASTM F1862	32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested	32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested
Particulate Filtration Efficiency ASTM F2299	≥ 95%	≥ 95%
Bacterial Filtration Efficiency ASTM F2101	≥ 95%	≥ 95%
Differential Pressure (Delta P) EN14683 Annex C	< 5.0mmH2O/cm²	< 5.0mmH2O/cm²
Flammability 16 CFR 1610	Class 1	Class 1
Biocompatibility ISO 10993-1	Meets requirements of ISO 10993-1 for Cytotoxicity, Skin Irritation, Sensitization	Met all evaluation acceptance criteria for Cytotoxicity, Irritation, and Sensitization

Information Not Applicable to this Document (as it's not an AI/ML device)

The remaining points of your request are specifically for an AI/ML medical device and are not present or applicable in this document for a physical medical product like face masks:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

This document clearly states: "No clinical study is included in this submission." (Page 7, Section 9). The testing performed is non-clinical and pertains to the physical and biological characteristics of the face mask material and construction.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

January 3, 2023

Anqing Mayfield Medical Limited Kevin Huang Official Correspondent Jingwu Road, Tongcheng Economic and Technological Development Zone Anging, Anhui 231400 China

Re: K222809

Trade/Device Name: Medical Disposable Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 26, 2022 Received: January 3, 2023

Dear Kevin Huang:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 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,

Brent Showalter -S

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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Indications for Use

510(k) Number (if known) K222809

Device Name Medical Disposable Face Masks

Indications for Use (Describe)

The Medical Disposable Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date of Preparation: September 1, 2022

1. Submitter:

510(k) Owner's Name: Anqing Mayfield Medical Limited Address: Jingwu Road, Tongcheng Economic and Technological Development Zone, Anging, Anhui, CN 231400 Contact Person: Minghan Zhou Title: General Manager Email: aqmayfield@163.com Tel: +86-18601137753 Fax: +86-556-6961888

2. Submission Correspondent:

Contact Person: Kevin Huanq Email: Kevin huang1021@Sina.com Tel: +86-13602471659 Fax: +86-20- 84558599

3. Identification of the Device

Device Name: Medical Disposable Face Masks Common Name: Face Mask, Surqical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Classification: Class II Product Code: FXX

4. Identification of the Primary Predicate Device

510(k) Number: K214087 Trade/Device Name: Medical Face Mask Common Name: Surgical Mask Manufacturer: Hubei Medlink Healthcare Co., Ltd Requlation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Classification Name: Surgical Face Mask Classification: Class II Product Code: FXX

5. Indications for Use

6. Device Description

The Medical Disposable Face Mask is blue color, single use, three-layer, flat-pleated mask with nose piece and ear loop. The blue colorant is polypropylene (PP) masterbatch.

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The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of polyester and spandex, not made with natural rubber latex.

The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum with polypropylene (PP) covering. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.

The medical face masks are available in two size specifications, 17.5×9.5cm, 14.5×9.5cm. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.

7. Substantial Equivalence-Comparison to Predicate Devices

A side by side comparison of the proposed device and the predicate device are provided below.

Comparison between proposed device and predicate device
Comparison Items	Proposed Device	Predicate Device	Discussion of Differences
Devece Name	Medical Disposable FaceMasks	Medical Face Mask	Similar
510k Number		K214087	---
Product Code	FXX	FXX	Same
RegulationNumber	21 CFR 878.4040	21 CFR 878.4040	Same
Regulatory Class	Class II	Class II	Same
Indications forUse	The Medical DisposableFace Mask is intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. The face mask isintended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is a singleuse, disposable device,provided non-sterile.	The Medical Disposable FaceMask is intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. The face mask isintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. This isa single use, disposabledevice(s), provided non-sterile.	Same
Sizespecification(Dimension)	17.5×9.5cm14.5×9.5cm	17.5×9.5cm16×9.5cm15.5×9.5cm14.5×9.5cm14×9.5cm	Similar.The proposed device'ssizes are included withinthe size range of thepredicate device whichhave been approved byFDA in K214087.
Color	Blue	Blue	Same
Design Feature	Ear Loops, Flat-pleated, 3layers	Ear Loops, Flat-pleated, 3layers	Same
	Use	Single Use, Disposable	Single Use, Disposable	Same
Materials	Outer layer	Spunbond Polypropylene	Spunbond Polypropylene	Same
	Inner layer	Spunbond Polypropylene	Spunbond Polypropylene	Same
	Middle layer(Filter layer)	Melt-blown Polypropylene	Melt-blown Polypropylene	Same
	Nose piece	Aluminum withPolypropylene (PP)covering	Malleable polyethylene wire	Different.The proposed device hasdifferent material of nosepiece and ear loop to thepredicatedevice,thebiocompatibility test hasbeen conducted on thefinal finished device andtest results show that theproposed device can meetthe requirements of ISO10993. Therefore,thedifferencesinthematerials don't raise anyadditional questions forsafety and effectiveness.
	Ear loop	Polyester, Spandex	Spandex
	OTC use	Yes	Yes	Same
	Sterility	Non-Sterile	Non-Sterile	Same
	ASTM F2100Level	Level 1	Level 1	Same
	Fluid ResistancePerformanceASTM F1862	32 out of 32 per lot pass at80 mmHg, 3 non-consecutive lots tested	32 out of 32 per lot pass at 80mmHg, 3 non-consecutivelots tested	Same
	ParticulateFiltrationEfficiencyASTM F2299	≥ 95%	≥ 95%	Same
	Bacterial FiltrationEfficiencyASTM F2101	≥ 95%	≥ 95%	Same
	DifferentialPressure(Delta P)EN14683 Annex C	< 5.0mmH2O/cm²	< 5.0mmH2O/cm²	Same
	Flammability16 CFR 1610	Class 1	Class 1	Same
	Biocompatibility	ISO 10993-1CytotoxicitySkin IrritationSensitization	ISO 10993-1CytotoxicityIrritationSensitization	Same.All the human contactcomponents aremanufactured frommaterials that meet all therequirements ofbiocompatibility, thematerials in contact weretested as per ISO 10993-

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The Medical Disposable Face Masks described in this 510(k) have similar technological and performance characteristics to the predicate device.

The proposed device has the same classification information, same indications for use and technological characteristics as compared to the predicate device. Any difference that exists between the Medical Disposable Face Masks and the predicate device have no negative effect on safety or effectiveness, or raise different questions of safety and effectiveness. The

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similarities and differences between the proposed and predicate device have been identified and explained in the comparison matrix which has been included in Section 12 of this submission.

Therefore, the proposed Medical Disposable Face Masks are substantially equivalent to the Medical Face Mask(K214087). The proposed device has the same classification information, same indications for use and technological characteristics as compared to the predicate device.

8. Summary of Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004

1) Performance Testing

Performance testing was carried out to verify the safety and the effectiveness of the subject device.

Nonclinical functional performance testing was performed in accordance with:

ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks

ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) > ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus > ASTM F2299/F2299M-03 (R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

EN 14683:2019+AC:2019 Medical Face Masks - Requirements and Test Methods

16 CFR 1610 Standard for the Flammability of Clothing Textiles

Testing datas and results are included in this submission, and demonstrated that the Medical Disposable Face Mask meets all the pre-determined testing and acceptance criteria.

2) Biocompatibility

The contact duration of the proposed device Medical Disposable Face Mask is less than 24 hours. According to ISO 10993-1:2018 Annex A Table A.1 and FDA Biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" published on June 16, 2016, the Medical Disposable Face Mask is considered a Surface Device that comes in contact with the Skin for limited exposure (<24 hours). The following tests were performed: Cytotoxicity, Irritation and Sensitization.

Biocompatibility was completed on the Medical Disposable Face Masks according to the following standards:

ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation And .

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Testing Within A Risk Management Process

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

Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible. All evaluation acceptance criteria were met.

Conclusions Drawn from the Non-Clinical Testing

The results of these tests demonstrate that the device is as safe, as effective, and performs as well as the identified predicate and support a determination of substantial equivalence.

9. Clinical Test Conclusion

No clinical study is included in this submission.

10. Conclusion

The Medical Disposable Face Masks is substantially equivalent to predicate device Medical Face Mask(K214087). Based on the indications for use, principle of operation, performance characteristics, and technological characteristics, the proposed Medical Disposable Face Mask is substantially equivalent to and as safe, as effective and performs as the legally marketed predicate device K214087.

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.