The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the 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 Protective Face Masks for Medical Use are flat-folded masks are three layers of materials consisting of polypropylene spun-bond (outer layer and inner layer), polypropylene melt-blown (middle layers). The masks contain a conformable nose piece enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, elastic ear loops not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in white. The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for a "Protective Face Mask for Medical Use." It assesses the substantial equivalence of the proposed device to predicate devices. The study conducted is a non-clinical performance test, not a study involving human readers or AI.

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

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

Methodology	Purpose	Acceptance Criteria	Reported Device Performance
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	≥ 98%	98.9~99.9%
ASTM F2101-19	Bacterial Filtration Efficiency	≥ 98%	98.9~99.9%
EN 14683:2019 Annex C	Differential Pressure	< 6.0mmH2O/cm²	4.0~5.6 mmH2O/cm²
16 CFR 1610	Flammability	Class I non flammable	non flammable
ISO 10993-5: 2009	Biological Evaluation - In Vitro Cytotoxicity	Confirmed to meet requirements	Pass
ISO 10993-10: 2010	Biological Evaluation - Irritation And Skin Sensitization	Confirmed to meet requirements	Pass

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

Sample Size:
- Fluid Resistance Performance: 32 samples (indicated by "32 out of 32 pass")
- For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), the exact sample size is not explicitly stated, but the results are reported as meeting the criteria.
Data Provenance: The tests were conducted to support the 510(k) submission from Hunan Heng Chang Pharmaceutical Co., Ltd. in China. The study is a non-clinical performance test of the device itself, not a study based on patient data, so "retrospective or prospective" and "country of origin of the data" in the typical clinical sense are not applicable. It's a laboratory-based device performance evaluation.

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)

Not applicable. This is a submission for a medical face mask, evaluated against established performance standards (ASTM, EN, ISO, CFR) through physical and biological testing, not through expert interpretation of medical images or diagnoses. Ground truth is defined by the objective measurement criteria of these standards.

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

Not applicable. This document describes laboratory performance testing, not a study involving human interpretation or adjudication. The results are based on objective measurements according to defined test methods.

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

No MRMC comparative effectiveness study was done. The submission 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

This is not applicable, as the device is a physical medical face mask, not an AI algorithm.

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

The "ground truth" for the non-clinical tests is represented by the objective acceptance criteria defined in internationally recognized standards such as ASTM F1862M-17, ASTM F2299, ASTM F2101-19, EN 14683:2019 Annex C, 16 CFR 1610, ISO 10993-5: 2009, and ISO 10993-10: 2010. These standards specify how the device should perform under controlled laboratory conditions.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. As above, this is a physical device, not an AI model.

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). 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.

January 29, 2021

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: K202358

Trade/Device Name: Protective Face Mask for Medical Use Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 23, 2020 Received: December 28, 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.

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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 (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 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. 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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Indications for Use

510(k) Number (if known) K202358

Device Name Protective Face Mask for Medical Use

Indications for Use (Describe)

The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile/sterile.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)	☒

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510(k) summary: K202358

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: Dec.23, 2020

II. Proposed Device

Trade Name of Device:	Protective Face Mask for Medical Use
Common name:	Surgical Mask
Regulation Number:	21 CFR 878.4040
Regulatory Class:	Class II
Product code:	FXX
Review Panel:	General Hospital
510(k) Number:	K202358

III. Predicate Devices and Reference Device

Predicate device

510(k) Number:	K143287
Trade name:	FLUIDSHIELD Surgical Mask with Expanded Chamber
Common name:	Surgical Mask
Classification:	Class II
Product Code:	FXX
Manufacturer:	Halyard Health, Inc.

Reference Device

510(k) Number:	K160271
Trade name:	N95 Particulate and Surgical Mask, Models TN01-11 andTN01-12
Common name:	Surgical Respirator

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Classification:	Class II
Product Code:	MSH
Manufacturer	San-M Package Co., Ltd.

IV. Device description

The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/sterile.

V. Indication for use

VI. Comparison of technological characteristics with the predicate devices

Item	Proposed device(K202358)	Predicate device(K143287)	Reference device(K160271)	Discussion
Product name	Protective Face Maskfor Medical Use	FLUIDSHIELDSurgical Mask withExpanded Chamber	N95 Particulate andSurgical Mask,Models TN01-11 andTN01-12	-
Product Code	FXX	FXX	MSH	Similar
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	21 CFR 878.4040	Same
Class	Class II	Class II	Class II	Same

Table 1-Comparison of proposed device and predicate devices

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Mask style		Expanded Chamber(Duckbill) Flat-fold,headband ties , 4Layers	Flat-fold, Headband, 4Layers	Similar1
Indicationfor use	The Protective FaceMask for Medical Useis intended to worn bythe healthcarepersonnel duringprocedure to protectboth the patient andthe healthcarepersonnel from thetransfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intendedfor use in infectioncontrol practices toreduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), providednon-sterile/sterile.	The ExpandedChamber SurgicalFace Mask isintended to be worn toprotect both thepatient and healthcarepersonnel fromtransfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intendedfor use in infectioncontrol practices toreduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), providednon-sterile.	The N95 ParticulateRespirator andSurgical Mask,Models TN01-11 andTN01-12 are singleuse , disposabledevices, providednon-sterile and areintended to be wornby operating roompersonnel or otherhealthcare workers toprotect both thepatient and operatingroom personnel fromof microorganisms,body fluids andparticulate material.	Similar topredicatedeviceDifferentfromreferencedevice
Material	Innerlayer	Spun-bondpolypropylene	Polyethylene/Polyester	Polypropylene andpolyethylene	Different2
	Middlelayer	Melt blownpolypropylene filter	Middle layer #1:PolypropyleneSpunbondMiddle layer #2:PolypropyleneMeltblown	Two filter layersPolypropylenemeltblown	Similar
	Outerlayer	Spun-bondpolypropylene	Top Half: BluePolypropyleneSpunbond (w Print)Bottom Half: WhitePolypropylene	Polypropylenespunbond	Similar
	Ear loop/head band	Spandex + Polyester	Polyester Spunlace orPolypropyleneSpunbond	Polyurethane, notmade with naturalrubber latex	Different2
	Nose piece	Outer plastic, inneraluminum wire,Sponge strips	Unknown	Polyethylene coatedsteel wire	Different2
Offered with Visor		No	Yes	No	Different
Color		White	Top Half: BlueBottom Half: White	Orange / White	Different2
Dimensions		Length: 16cmWidth: 20cm	Length: 19cmWidth: 21cm	TN01-12 (Small):Length: 205 ± 5 mmWidth: 75 ± 5 mmBand length: 205 ± 5 mmTN01-11 (Medium):Length: 240 ± 5 mmWidth: 75 ± 5 mmBand length: 240 ± 5 mm	Different3
OTC use		Yes	Yes	Yes	Same
Sterility		Non-sterile/sterile	Non-sterile	Non-sterile	Different4
For single use		Yes	Yes	Yes	Same
ASTMF2100 Level		ASTM F 2100-19,Level 2	ASTM F2100-11,Level 2	ASTM F2100-11,Level 3	Similar4
Fluid ResistancePerformance		pass at 120mmHg	pass at 120mmHg	pass at 160mmHg	Same as thepredicate device
Particulate FiltrationEfficiency		≥98%	≥98%	NIOSH Certification#TC 84A-3348(includes TN01-11 &TN01-12)	Same as thepredicate device
Bacterial		≥98%	≥98%	NIOSH Certification	Same as the
FiltrationEfficiency			#TC 84A-3348(includes TN01-11 &TN01-12)	predicatedevice
DifferentialPressure	<6.0mmH2O/cm²	<5.0mmH2O/cm²	NIOSH Certification#TC 84A-3348(includes TN01-11 &TN01-12)	Similar4
Flammability	Class Iflammable	non	Class I non flammable	Same
Biocompatibility	Confirm to therequirements of ISO10993 seriesstandards	Confirm to therequirements of ISO10993 seriesstandards	Confirm to therequirements of ISO10993 seriesstandards	Same

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1 The physical feature of the proposed device has minor difference from the predicate device. But the proposed device has similar mask shape with the reference device, which it is a surgical respirator. Both of them have the similar indications. The conclusion can be drawn out that the different mask style does not affect the indications of the device.

2 The difference in the materials does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.

3 Compare with the predicate and reference device, the different of the physical feature or size does not affect the intended use of the subject device.

4 The subject device (sterile or non-sterile) has performed performance test according to the ASTM F 2100-19. The test results demonstrate that meet the acceptance criteria.

VII. 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 tests article, which demonstrated that the proposed device complies with the following standards:

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Methodology	Purpose	Acceptance Criteria	Results
ASTMF1862M-17	Fluid ResistancePerformance	29 out of 32 passat 120mmHg	32 out of 32 passat 120mmHg
ASTM F2299	ParticulateFiltration Efficiency	$\geq$ 98%	98.9~99.9%
ASTM F2101-19	Bacterial FiltrationEfficiency	$\geq$ 98%	98.9~99.9%
EN 14683:2019Annex C	DifferentialPressure	<6.0mmH2O/cm²	4.0~5.6mmH2O/cm²
16 CFR 1610	Flammability	Class I nonflammable	non flammable

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 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 Test Methods ●
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. 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 the predicate

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device, FLUIDSHIELD Surgical Mask with Expanded Chamber (K143287).

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.