The Surgical Face 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, provided non-sterile.

Device Description

The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Masks will be provided in blue. The medical face masks are sold nonsterile and are intended to be single use, disposable devices. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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. 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 wire.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Surgical Mask, based on the provided document:

Acceptance Criteria and Device Performance

Test Method (ITEM)	Acceptance Criteria (Level 2)	Reported Device Performance
Fluid Resistance Performance (ASTM F1862-13)	Pass at 120 mmHg	182 out of 182 pass at 120 mmHg
Particulate Filtration Efficiency (ASTM F2299)	≥ 98%	98.40%
Bacterial Filtration Efficiency (ASTM F2101)	≥ 98%	99.86%
Differential Pressure (Delta P) (MIL-M-36954C)	< 6.0 mmH2O/cm²	5.3 mmH2O/cm²
Flammability (16 CFR 1610)	Class 1	Class 1
Cytotoxicity (ISO 10993-5)	Comply with ISO 10993-5 (non-cytotoxic)	Not cytotoxic
Irritation (ISO 10993-10)	Comply with ISO 10993-10 (non-irritant)	Not an irritant
Sensitization (ISO 10993-10)	Comply with ISO 10993-10 (non-sensitizer)	Not a sensitizer

Study Information

The provided document describes non-clinical tests conducted to demonstrate that the proposed device meets its design specifications and acceptance criteria. This is primarily a standalone performance study as it evaluates the device's physical and biological properties.

Sample sizes used for the test set and data provenance:
- Fluid Resistance (ASTM F1862-13): "182 out of 182 pass." This indicates a sample size of 182 masks were tested for fluid resistance.
- For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, specific sample sizes are not explicitly stated for the "Proposed Device" results, but the footnote mentions "Acceptable sampling plans are found in ISO 2859-1 with an acceptable quality limit of 4 %". This implies that standard sampling methods were followed.
- Biocompatibility: The results (non-cytotoxic, non-irritating, non-sensitizing) are qualitative statements, and specific numerical sample sizes for these tests are not provided in the summary.
- Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests, nor does it explicitly state whether the study was retrospective or prospective. Given the nature of performance testing for device submission, it's generally prospective as the tests are conducted specifically for the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-clinical, laboratory-based performance study, not a study requiring expert consensus for ground truth on patient outcomes or diagnoses. The "ground truth" is defined by the established ASTM and ISO standards and test methodologies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is typically used in clinical studies when interpreting ambiguous cases or disagreeing expert opinions. For objective laboratory tests, the results are quantitative or qualitative assessments against defined criteria, not subject to human adjudication in this sense.
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, a MRMC comparative effectiveness study was not done. This device is a surgical mask, and the evaluation focuses on its physical and biological performance characteristics, not on the effectiveness of human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The non-clinical tests described are evaluations of the device's intrinsic properties and performance, independent of human interaction or interpretation beyond performing the test procedures.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these non-clinical tests is based on established industry standards and test methodologies (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, MIL-M-36954C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured against the quantitative and qualitative requirements set forth in these standards.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The "device" in question is a physical product (surgical mask). The tests evaluate its performance characteristics directly.
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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December 14, 2021

Chongqing Pa Xijia Biotechnology Co., Ltd. % May Wu Manager of Business Development Sichuan JIULUEHUI Consulting Co., Ltd. Room 1401, Building 4, No. 666, Chenglong Avenue Chengdu, Sichuan 610101 China

Re: K210744

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 21, 2021 Received: October 29, 2021

Dear May Wu:

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,

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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Indications for Use

510(k) Number (if known) K210744

Device Name Surgical Mask

Indications for Use (Describe)

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)

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510(k) Summary - K210744

This summary of 510(k) is being submitted in accordance with requirements of the SMDA 21 CFR 807.92.

1. Date of Prenaration: February 28, 2021

Sponsor Identification 2.

Chongqing Pa Xijia Biotechnology Co., Ltd. No. 27-5, Fengsheng Road, Jiulongpo District,Chongqing,China

Contact Person: Zheng Tao Position: Head of Firm Tel: +86-23-68085022

3. Designated Submission Correspondent

Miss. May Wu Sichuan JIULUEHUI Consulting Co., Ltd. Room 1401, Building 4, No. 666, Longcheng Avenue, Chengdu City, Sichuan Province, China Tel: +86-18123234232 Email: consulting(@sc9lh.cn

4. Device Information

Trade name: Surgical Mask Common name: Surgical Face Mask Model: Ear-loop

5. Classification

Production code: FXX Regulation number: 21 CFR 878.4040 Classification: Class II Classification name: Surgical Face Mask Review Panel: Surgical Apparel

Indication for Use Statement 6.

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7. Device Descrintion

The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece.

The Surgical Masks will be provided in blue. The medical face masks are sold nonsterile and are intended to be single use, disposable devices.

The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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. 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 wire.

8. Identification of Predicate Device(s)

Manufacturer: Xiantao Rayxin Medical Products Co., Ltd. Disposable Surgical Face Mask Device: 510(k) number: K153496

9. Technological Characteristics Comparison Table

Table 1 General Comparison
Item	Proposed DeviceK210744	Predicate DeviceK153496	Comparison
ProductName	Surgical Mask	Disposable Surgical FaceMasks	--
ProductCode	FXX	FXX	Same
RegulationNo.	21 CFR878.4040	21 CFR 878.4040	Same
ProductClass	II	II	Same
ProductCode	The Surgical Face Masks areintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids and particulate material.These face masks are intended for usein infection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device,provided non-sterile	The Disposable Surgical FaceMasks are intended to be worn toprotect both the patient andhealthcare personnel from transferof microorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood andbody fluids. This is a single use	Same

Table 1 General Comparison

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			disposable device(s), providednon-sterile.
Designfeatures	Ear Loops, 3 layers		Ear Loops, Tied-On, 3 layers	Same
MaskStyles	Flat pleated		Flat pleated	Same
Material	Outerfacinglayer	Spun-bond polypropylene	Spun-bond polypropylene	Similar
	Middlelayer	Melt blown polypropylenefilter	Melt blown polypropylene filter	Similar
	InnerFacinglayer	Spun-bond polypropylene	Spun-bond polypropylene	Similar
	Nosepiece	Malleable aluminum wire	Malleable aluminum wire	Similar
	Earloops	Polyester	Polyester	Similar
Color	Blue		Blue	Similar
Mask Size	M(152mmX70mm),L(175mmX90mm),XL(180mmX100mm)		175mmX90mm	Different
OTC use	Yes		Yes	Same
Sterility	Non-Sterile		Non-Sterile	Same
Single Use	Yes		Yes	Same
Sterile	No		No	Same
ASTMF2100Level	Level 2		Level 2	Same

Table2 Performance Characteristic Comparison

ITEM	Proposed Device	Predicate Device	ASTM F2100Requirements forLevel 2Classification	Comparison
Fluid ResistancePerformance ASTMF1862-13	182 out of 182 passat 120 mmHg	32 out of 32 pass at120 mmHg	Pass at 120mmHg*	Similar
Particulate FiltrationEfficiencyASTM F2299	98.40%	98.46%	≥ 98%*	Similar
Bacterial FiltrationEfficiency ASTM F2101	99.86%	98.70%	≥ 98%*	Similar
Differential Pressure(Delta P)MIL-M-36954C	5.3 mmH2O/cm2	4.2 mmH2O/cm2	< 6.0mmH2O/cm2*	Similar

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Flammability16 CFR 1610	Class 1	Class 1	Class 1*	Same
-----------------------------	---------	---------	----------	------

Acceptable sampling plans are found in ISO 2859-1 with an acceptable quality limit of 4 %

ITEM	Proposed Device	Predicate Device	BiocompatibilityRequirement	Comparison
Cytotoxicity	Under the conditionsof the study, notcytotoxicity effect	Under the conditionsof the study, notcytotoxicity effect	Comply with ISO10993-5	Similar
Irritation	Under the conditionsof the study, not anirritant	Under the conditionsof the study, not anirritant	Comply with ISO10993-10	Similar
Sensitization	Under conditions ofthe study, not asensitizer	Under conditions ofthe study, not asensitizer		Similar

Table 3 Biocompatibility Comparison

10. Non-Clinical Test Conclusion

Non-clinical tests were conducted on three nonconsecutive lots to demonstrate that the proposed device met all design specifications or acceptance criteria in the standard and test methodology.

Test Method	Purpose	Acceptance Criteria Level 2	Results
ASTM F2100-19e1ASTM F2101-19Bacterial Filtration Efficiency Test(BFE), %	The purpose of the testingwas to measure theBacterial Filtration EfficiencyTest	$\ge$ 98	Pass
ASTM F2100-19e1EN 14683:2019+AC:2019(E)Annex CDifferential Pressure Test(mm H2O/cm²)	The purpose of the testingwas to measure theDifferential Pressure Test	< 6.0	Pass
ASTM F2100-19e1ASTM F2299/F2299M- 2003(2017)Sub-Micron Particulate FiltrationEfficiency (PFE) at0.1 micron Test (%)	The purpose of thetesting was to measurethe Sub-Micron ParticulateFiltration Efficiency	$\ge$ 98	Pass

Table 1 Performance Test Result Summary

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ASTM F2100- 19e1 ASTMF1862/F1862M-17Resistance toPenetration by Synthetic Blood Test(minimum pressure in mmHg for passresult)	The purpose of the testingwas to measure thePenetration by SyntheticBlood Test	120	Pass
ASTM F2100-19e116 CFR Part 1610-2012Flammability Test	The purpose of the testingwas to measure theFlammability	Class 1	Pass

Table2 Biocompatibility Testing

Item	Subject Device	Result
Cytotoxicity	Under the conditions of the study, the device is noncytotoxic.	Pass
Irritation	Under the conditions of the study, the device is nonirritating.	Pass
Sensitization	Under the conditions of the study, the device is nonsensitizing	Pass

11. Clinical Test Conclusion

No clinical study is included in this submission.

12. 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 predicate device, Xianto Rayxin Medical Products Disposable Surgical Face Mask cleared under 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.