The Surgical Masks are 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(s), provided non-sterile/ sterile.

Device Description

The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Face Masks are manufactured with three layers. The outer layer is made of spunbonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of polypropylene (PP) fabric. The Surgical Masks are single use, disposable device, provided non-sterile/sterile.

AI/ML Overview

The provided text is a 510(k) Summary for a Surgical Mask (K202354). It details non-clinical performance testing for the device. Clinical studies (multi-reader multi-case, standalone, etc.) were explicitly not part of this submission, as stated in Section VIII: "No clinical study is included in this submission." Therefore, the information regarding expert adjudication, ground truth establishment for a training set, and the specific details of comparative effectiveness studies (MRMC) are not applicable to this submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Methodology	Purpose	Acceptance Criteria	Reported Device Performance Results
ASTM F1862M-17	Fluid Resistance Performance	29 out of 32 pass at 120mmHg	32 out of 32 pass at 120mmHg
ASTM F2299	Particulate Filtration Efficiency	≥95%	95.8~96.8%
ASTM F2101-19	Bacterial Filtration Efficiency	≥95%	98.3~99.2%
EN 14683:2019 Annex C	Differential Pressure	< 5.0mmH2O/cm²	3.7~3.8 mmH2O/cm²
16 CFR 1610	Flammability	Class I non flammable	non flammable

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

The document does not explicitly state the specific sample size for each test, but for Fluid Resistance, it mentions "29 out of 32 pass at 120mmHg" for the acceptance criteria and "32 out of 32 pass at 120mmHg" for the results, implying a sample size of 32 for that specific test.

The data provenance is from Hunan Heng Chang Pharmaceutical Co., Ltd. in China. The tests are described as "non clinical performance tests," which are typically laboratory-based and generally considered prospective for the device's validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not Applicable. This submission is for a surgical mask based on non-clinical performance testing against established standards, not an AI/imaging device requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, this is non-clinical performance testing against objective standards, not a diagnostic accuracy study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. The document explicitly states: "No clinical study is included in this submission."

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

No. This is a physical medical device (surgical mask), not a software algorithm. The performance evaluation is based on material and structural properties as tested in laboratory settings.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective measurements against recognized industry standards. These include:

Fluid penetration resistance (synthetic blood)
Particulate filtration efficiency
Bacterial filtration efficiency
Differential pressure (breathability)
Flammability

These standards specify the methodology and acceptance criteria for measuring these physical properties.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. As per point 8, there is no training set for this device.

Summary

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September 8, 2020 Hunan Heng Chang Pharmaceutical Co., Ltd. % Shelley Li Director Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai. 200071 China

Re: K202354

Trade/Device Name: Surgical Mask-Model Number CW01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2020 Received: August 19, 2020

Dear Shelley Li:

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 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,

For CAPT Elizabeth Claverie, M.S. 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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Indications for Use

510(k) Number (if known) K202354

Device Name Surgical Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Registration Use (Part 21 CFR 201.2 Subject to Review)	Over-The-Counter Use (21 CFR 201.2 Subject to Review)
---------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------

_ | 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: K202354

I Submitter

Hunan Heng Chang Pharmaceutical Co., Ltd.

Floor 2, 3, 102 of Building 16, Standard Plant of Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Kaifu District, Changsha 410000, China

Contact person: Tao Jingfeng Position: QC Manager Tel.: ++86-18774961605 E-mail: taojingfeng@hcyy.com

Preparation date: Aug. 27, 2020

II Proposed Device

Trade Name of Device:	Surgical Mask
Common name:	Surgical Mask
Regulation Number:	21 CFR 878.4040
Regulatory Class:	Class II
Product code:	FXX
Review Panel:	General Hospital
510(k) Number:	K202354

III Predicate Devices

510(k) Number:	K153496
Trade name:	Disposable Surgical Face Mask
Common name:	Surgical Mask
Classification:	Class II
Product Code:	FXX
Manufacturer	Xiantao Rayxin Medical Product Co., Ltd

IV Device description

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contact with face is made of polypropylene (PP) fabric.

The Surgical Masks are single use, disposable device, provided non-sterile/sterile.

V Indication for use

Item	Proposed device(K202354)	Predicate device(K153496)
Product name	Surgical Mask	Disposable Surgical FaceMask
Product Code	FXX	FXX
Regulation No.	21 CFR 878.4040	21 CFR 878.4040
Class	Class II	Class II
Mask style	Flat-pleated, ear loop, 3layers	Flat-pleated, ear loop, tie-on,3 layers
Indication for use	The Surgical Masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile/ sterile.	The Disposable SurgicalFace Masks are intended tobe worn to protect both thePatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. This isa single use, disposabledevice(s), provided non-sterile.
Material	InnerSpun-bond polypropylene	Spun-bond polypropylene

VI Comparison of technological characteristics with the predicate devices

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	layer
	Middle layer	Melt blown polypropylene filter	Melt blown polypropylene filter
	Outer layer	Spun-bond polypropylene	Spun-bond polypropylene
	Ear loop	Spandex + Polyester	Polyester
	Nose piece	malleable polyethylene	Malleable aluminum wire
Color		Blue	blue
Length		$17.5 cm±5%$	$17.5±1cm$
Width		$9.5 cm±5%$	$9.5±1cm$
OTC use		Yes	Yes
sterile		Non-sterile, sterile	Non-sterile
Sterilization method		EO	/
Single for use		Yes	Yes
ASTM F2100 Level		Level 1	Level 2
Biocompatibility		Confirm to the requirements of ISO 10993 series standards	Confirm to the requirements of ISO 10993 series standards

VII Summary of Non-Clinical Testing

Non clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the following standards:

Methodology	Purpose	Acceptance Criteria	Results
ASTM F1862M-17	Fluid ResistancePerformance	29 out of 32 passat 120mmHg	32 out of 32 passat 120mmHg
ASTM F2299	Particulate FiltrationEfficiency	≥95%	95.8~96.8%
ASTM F2101-19	Bacterial FiltrationEfficiency	≥95%	98.3~99.2%

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EN 14683:2019Annex C	DifferentialPressure	< 5.0mmH2O/cm²	3.7~3.8mmH2O/cm²
16 CFR 1610	Flammability	Class I non flammable	non flammable

ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cvtotoxicity
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 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)
EN 14683:2019, Medical Face Mask-Test-Requirements and TestMethods; ●
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 medical face masks to penetration by particulates using latex spheres:
16 CFR 1610, Standard for the Flammability of clothing textiles; ●

VIII Summary of Clinical Testing

No clinical study is included in this submission.

IX Conclusion

The conclusion drawn from the non-clinical performance testing data demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate device, Disposable Surgical Face Mask (K153496).

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.