The Protective Face Mask for Medical Use 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 non-sterile.

Device Description

The Protective Face Mask for Medical Use is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a malleable aluminum strip covered with sponge, which is welded to the facemask top edge to allow the user to fit the facemask around their nose. The mask is a single use, disposable device, provided non-sterile in white color.

AI/ML Overview

This document is a 510(k) Premarket Notification submission for a medical device, specifically a "Protective Face Mask for Medical Use." It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a "Performance testing" table (Table 2) that directly addresses this point.

Test Items	Acceptance Criteria	Results
Fluid Resistance Performance (ASTM F1862M-17)	29 out of 32 pass at 120 mmHg	32 out of 32 pass at 120mmHg
Particulate Filtration Efficiency (ASTM F2299)	>98%	99.22%
Bacterial Filtration Efficiency (ASTM F2101-19)	>98%	99.89%
Differential Pressure (EN 14683:2019 Annex C)	<6.0 mm H2O/cm²	4.2 mmH2O/cm²
Flammability (16 CFR 1610)	Class 1 / Non-Flammable	Class 1 (not ignited)

Additionally, a "Biocompatibility testing" table (Table 3) is provided:

Testing Items	Standards	Results
Cytotoxicity	ISO 10993-5:2009	Pass (Non-Cytotoxic)
Irritation	ISO 10993-10:2010	Pass (Non-Irritating)
Sensitization	ISO 10993-10:2010	Pass (Non-Sensitizing)

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

Sample Size for Test Set:
- For Fluid Resistance Performance, the sample size is explicitly stated as 32 (implied by "32 out of 32 pass").
- For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) and all Biocompatibility tests, the exact sample size is not explicitly stated in this document. It is only reported that the tests were done and passed.
Data Provenance: The document does not specify the country of origin of the data for the tests. It states the submitter's address is in Jinan, Shandong, China, implying the testing could have been conducted in China, but this is not explicitly confirmed for the test data itself. The testing type is non-clinical testing, which is typically conducted in a laboratory setting, not a retrospective or prospective clinical study on human subjects for this type of device.

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

This information is not applicable to this submission. The "ground truth" for a surgical mask primarily relies on objective, standardized physical and biological performance tests (e.g., filtration efficiency, fluid resistance) conducted in laboratories, not on human expert consensus or interpretation of images/data, as would be the case for AI/image analysis devices. The standards themselves (e.g., ASTM, ISO, EN) define the accepted methods and criteria.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Laboratory tests for physical performance of a mask do not involve adjudication by multiple experts in the same way clinical data or imaging studies do.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study would be relevant for software or AI devices where human performance with and without AI assistance is being evaluated. This is a physical device (surgical mask) whose performance is evaluated through standardized laboratory tests.

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

Not applicable/No. This is not an algorithm or AI device. The testing conducted was standalone performance of the physical mask itself in laboratory conditions, according to specified standards.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective, standardized laboratory measurements and adherence to established industrial and medical device standards (e.g., ASTM F1862M-17 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101-19 for bacterial filtration, EN 14683:2019 Annex C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 series for biocompatibility). These standards define the acceptable performance thresholds.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a software/AI device that requires a "training set" for machine learning.

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

This information is not applicable for the same reason as point 8.

Summary

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September 4, 2020

Shandong Shengquan New Material 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: K201537

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: June 4, 2020 Received: June 8, 2020

Dear Ms. 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.

Elizabeth Claverie, MS 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) K201537

Device Name Protective Face Mask for Medical Use

Indications for Use (Describe)

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)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone, Zhanggiu District, Jinan 250204 Shandong, China. Establishment Registration Number: 3016688828

Contact person: Xiumei Zhang Position: QC Manager Tel.: +86-13864136816 Fax: +86-21-34622840 E-mail: zhangxiumei@shengquan.com Preparation date: Sept. 02, 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

III. 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.

IV. Device description

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The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.

The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a malleable aluminum strip covered with sponge, which is welded to the facemask top edge to allow the user to fit the facemask around their nose. The mask is a single use, disposable device, provided non-sterile in white color

V. Indication for use

VI. Comparison of technological characteristics with the predicate device

Item	Proposed device	Predicate device(K143287)	Comparison
Product name	Protective Face Mask forMedical Use	FLUIDSHIELD Surgical Maskwith Expanded Chamber	-
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Classification	Class II	Class II	Same
Mask style	Expanded chamberflat-folded, ear loops,4 layers	Expanded chamber (Duckbill)flat-folded, headband ties,4 layers	Similar
Indication for use	The Protective Face Maskfor Medical Use is intendedto be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.The face mask is intended	The Expanded ChamberSurgical Face Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Theseface masks are intended for	Same

Table 1: General Comparison

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		for use in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle use, disposabledevice, provided non-sterile.	use in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is a singleuse, disposable device(s),provided non-sterile.
	Inner layer	Spun-bond polypropylene	Polyethylene/Polyester	Different
	Middle layer	polypropylene non-wovenfabric	Spun-bond polypropylene	Different
	Outer layer	Melt-blown polypropylene	Melt-blown polypropylene	Same
		Spun-bond polypropylene	Top Half: Blue spun-bondpolypropylene (w Print)Bottom Half: White spun-bondpolypropylene	Similar
	Earloop/headband	Spandex + Polyester	Polyester spunlace orspun-bond polypropylene	Similar
	Nose piece	Plastic coated aluminumwire covered with spongestrips	Unknown
Color		White outer layer and grayinner layer	Top Half: BlueBottom Half: White	Different
Size		Length: 16.5±0.8cmWidth: 10.5±0.5cm	Length: 21.0±1.0 cmWidth: 19.0± 0.3 cm	Different
OTC use		Yes	Yes	Same
Sterility		Non-sterile	Non-sterile	Same
Use		Single use, disposable	Single use, disposable	Same
ASTM F2100 Level		Level 2	Level 2	Same

VII. Non-Clinical Testing

The proposed device was tested and conformed to 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.

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Table 2: Performance testing

Test Items	Acceptance Criteria	Results
Fluid Resistance Performance	29 out of 32 pass	32 out of 32 pass
ASTM F1862M-17	at 120 mmHg	at 120mmHg
Particulate Filtration EfficiencyASTM F2299	>98%	99.22%
Bacterial Filtration EfficiencyASTM F2101-19	>98%	99.89%
Differential PressureEN 14683:2019 Annex C	<6.0 mm H2O/cm²	4.2 mmH2O/cm²
Flammability	Class 1	Class 1
16 CFR 1610	Non-Flammable	(not ignited)

Table 3: Biocompatibility testing

Testing Items	Standards	Results
Cytotoxicity	ISO 10993-5:2009	Pass (Non-Cytotoxic)
Irritation	ISO 10993-10:2010	Pass (Non-Irritating)
Sensitization	ISO 10993-10:2010	Pass (Non-Sensitizing)

VIII. Clinical Testing

No clinical study is included in this submission.

IX. Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated K143287, Halyard Health FLUIDSHIELD Surgical Mask with Expanded Chamber.

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.