The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks 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(s), provided non-sterile.

The Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.

Device Description

The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors, Blue color and White color. This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.

All two colors of the model YH-EZ-004 of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of spunbonded non-woven fabric, and the middle layer is made of melt-blown non-woven fabric.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene.

The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with terylene and spandex.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

AI/ML Overview

Based on the provided text, the device in question is a Surgical Mask, and the submission is a 510(k) premarket notification. This type of submission typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies for novel AI/ML-driven diagnostics.

Therefore, the requested information regarding AI/ML-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and standalone algorithm performance is not applicable to this document. This document describes the testing for physical and biological properties of the surgical masks to show they perform as well as a predicate device.

Here's the information that is applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the surgical masks are based on ASTM F2100 Level 2 requirements and other relevant standards.

ITEM	Acceptance Criteria	Results (Blue Color)	Results (White Color)
Performance Characteristics (ASTM F2100 Level 2 Requirement)
Fluid Resistance (ASTM F1862)	120 mmHg	120 mmHg	120 mmHg
Particulate Filtration Efficiency (ASTM F2299) at 0.1 micron	≥ 98%	≥ 99.30%	≥ 99.77%
Bacterial Filtration Efficiency (ASTM F2101)	≥ 98%	≥ 98.54%	≥ 99.04%
Differential Pressure (Delta P) (EN 14683 Annex C)	< 6.0 mm H2O/cm²	< 5.4mm H2O/cm²	< 5.0mm H2O/cm²
Flammability (16 CFR 1610)	Class 1	Class 1	Class 1
Biocompatibility (ISO 10993)
Cytotoxicity (ISO 10993-5)	No cytotoxicity effect	Under the conditions of the study, no cytotoxicity effect	Under the conditions of the study, no cytotoxicity effect
Irritation (ISO 10993-10)	No irritation effect	Under the conditions of the study, no irritation effect	Under the conditions of the study, no irritation effect
Sensitization (ISO 10993-10)	No sensitization effect	Under conditions of the study, no sensitization effect	Under conditions of the study, no sensitization effect

The study proves the device meets the acceptance criteria as indicated by the "Results" columns. All reported values fall within or exceed the specified acceptance criteria.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for fluid resistance). The studies are non-clinical bench tests performed on the physical masks themselves (e.g., measuring filtration efficiency, pressure drop, flammability, and conducting biocompatibility tests).
The provenance of the data is from non-clinical bench testing performed on the devices manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. in China. The tests are reported as "Nonclinical Test Conclusion," implying they were conducted in a laboratory setting to verify the device's design specifications. The studies are prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance with standards.

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

This concept is not applicable to a submission for surgical masks based on physical and biological performance testing. "Ground truth" in this context refers to the results of standardized laboratory tests performed by qualified personnel using specified methodologies. There is no mention of expert consensus or human interpretation being part of establishing "ground truth" for these performance metrics.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of results/labels. The tests are laboratory-based measurements against defined standards.

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 AI/ML-driven diagnostic aids where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (surgical masks).

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

Not applicable. This device is not an algorithm or software. Its performance is evaluated through physical and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance characteristics (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) and biocompatibility testing (ISO 10993). These are objective, quantitative measurements against predefined criteria.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

December 3, 2021

Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD., FangShan District Beijing, Beijing 102401 China

Re: K212807

Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 31, 2021 Received: September 3, 2021

Dear Ray Wang:

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 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, PhD 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K212807

Device Name Surgical Masks

Indications for Use (Describe)

The Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.

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

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in a ccordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation:2021/8/31
1. Sponsor Identification

WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.

No.567 Gushan Road , Area of Economy and Technique, Weihai City, Shandong Province, 264205, CHINA.

Contact Person:Bin Dong Position: Manager Tel: +86-15662383633 Fax: +86-0631-3636910 Email: dbfeel@163.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

1. Identification of Proposed Device
  Trade Name:Surgical Masks Common Name: Mask, Surgical

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

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Indication For Use Statement:

Device Description:

The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors,Blue color and White color.This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene.

The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with terylene and spandex.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

1. Identification of Predicate Device(s)
  510(K) number:K202594 Device name:Medical Surgical Masks-Non Sterile Manufacturer:SHANDONG T&F NONWOVEN CO., LTD.
1. Technological Characteristics Comparison

Table 1 General Comparison

ITEM	Proposed Device	Predicate Device K202594	Remark
	ASTM F2100 Level 2	ASTM F2100 Level 2
Intended Use	The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a	The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is intended for use in infection control practices to reduce the potential exposure to blood and body	SAME

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		single-use, disposable device(s), providednon-sterile.The Model YH-EZ-004(White Color, BlueColor) is Level 2 barrier as ASTM F2100requirements.	fluids. This is a single-use, disposabledevice(s), provided non-sterile.
	Basic Design	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Flat-Pleated, 3 layers	SAME
Materials	Outer Facing Layer	spunbonded non-woven fabric	polypropylene non-woven fabric	Analysis
	Middle Layer	melt-blown non-woven fabric	polypropylene melt-blown fabric
	Inner Facing Layer	spunbonded non-woven fabric	polypropylene non-woven fabric
	Nose Piece	polyethylene	PP + iron wire
	Ear Loops	terylene, spandex	polyamide and polyurethane
	Color	Blue, White	White	Analysis
Dimension(Length, Width)		17.5 cm ±5%cm9.5 cm ±5%cm	17.5 cm +/- 5mm9.5 cm +/- 5mm	Similar
	OTC use		Yes	Yes
Single Use		Yes	Yes	SAME
Sterile		Non-sterile	Non-sterile	SAME

Table 2 Performance Characteristic Comparison

ITEM	Proposed Device	Predicate Device K202594	ASTM F2100 Requirements	Remark
ASTM F2100Level	YH-EZ-004WhiteLevel 2	YH-EZ-004BlueLevel 2	Level 2	Level 2	SAME
Fluid ResistancePerformanceASTM F1862	120 mmHg	120 mmHg	120 mmHg	120 mmHg	SAME
ParticulateFiltrationEfficiency ASTMF2299	≥99.77%	≥99.30%	≥99%	≥ 98%
BacterialFiltrationEfficiency ASTMF2101	≥99.04%	≥98.54%	≥99%	≥ 98%
DifferentialPressure (Delta P)EN 14683:2019+AC:2019 Annex C	< 5.0 mmH2O/cm²	< 5.4mmH2O/cm²	< 4.8 mmH2O/cm²	< 6.0 mmH2O/cm²
Flammability16 CFR 1610	Class 1	Class 1	Class 1	Class 1	SAME

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Table 3 Biocompatibility Comparison

ITEM	Proposed Device	Predicate Device K202594	Remark
Cytotoxicity	Non-cytotoxic	Non-cytotoxic	SAME
Irritation	Non-irritating	Non-irritating	SAME
Sensitization	Non-sensitizing	Non-sensitizing	SAME

Analysis:

The proposed device is different with the predicate device in materials used and color, which may raise the risk about biocompatibility, for this risk we have conducted the testing according to the ISO10993-1, cytotoxicity, irritation and sensitization. The test results shown that no biocompatibility risk would be raised.

So, we consider that the proposed device has same biocompatibility performance with the predicate device.

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Medical Surgical Masks-Non Sterile cleared under K202594.

7. Non-Clinical Test Conclusion

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

A 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.
ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
EN 14683-2019+AC:2019 Annex C, Medical face masks Requirements and test methods; A
A 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 F2299-03, Stand test method for determining the initial efficiency of materials used in

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medical face masks to penetration by particulates using latex spheres;

16 CFR 1610, Standard for the Flammability of clothing textiles;
Bench Testing for the performance of Dimensions.

Test Method	Purpose	AcceptanceCriteria	Results(BlueColor)	Results(White Color)
ASTM F1862	Resistance topenetration bysynthetic blood	120 mm Hg	120 mm Hg	120 mm Hg
ASTM F2299	Sub-micronparticulate filtrationefficiency at 0.1micron	≥ 98%	≥ 99.30%	≥ 99.77%
ASTM F2101	Bacterial FiltrationEfficiency	≥ 98%	≥ 98.54%	≥ 99.04%
EN 14683Annex C	DifferentialPressure	< 6.0 mmH2O/cm²	< 5.4mm H2O/cm²	< 5.0mm H2O/cm²
16 CFR 1610	Flammability	Class 1	Class 1	Class 1
ISO 10993-10	Irritation	No irritationeffect	Under theconditions of thestudy, no irritationeffect	Under the conditionsof the study, noirritation effect
	Sensitization	No sensitizationeffect	Under conditionsof the study, nosensitizationeffect	Under conditions ofthe study, nosensitization effect
ISO 10993-5	Cytotoxicity	No cytotoxicityeffect	Under theconditions of thestudy, nocytotoxicity effect	Under the conditionsof the study, nocytotoxicity effect

8. Clinical Test Conclusion

No clinical study is included in this submission.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device K202594.

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.