The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

Device Description

The Surgical Face Masks are blue color, there-layer, flat-pleaded masks with nose piece and ear loops/ties, which are composed of outer layer, middle layer and inner layer. The outer layer and inner layer of the mask are made of polypropylene, the middle layer is made of melt-blown polypropylene. The ear loop/ties of the subject mask is held in place over the users' mouth and nose by two ear loops/ties welded to the face mask. The ear loop is made with polyester and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of high density polyethylene. The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100 Standard Specification for Performance of Materials Used in Surgical Face Masks.

AI/ML Overview

The provided document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is categorized as a "Level 3 Barrier" surgical face mask.

Test Methodology	Purpose	Acceptance Criteria for Level 3 Barrier	Reported Device Performance
Bacterial Filtration Efficiency (ASTM F2101)	Measure bacterial filtration efficiency	≥ 98%	Passed (≥ 98%)
Differential Pressure (EN 14683:2019 Annex C)	Determine breathability of the mask	< 6.0 mmH2O/cm2	Passed (< 6.0 mmH2O/cm2)
Sub-micron Particulate Filtration Efficiency (ASTM F2299-17)	Measure initial particle filtration efficiency	≥ 98%	Passed (≥ 98%)
Resistance to Penetration by Synthetic Blood (ASTM F1862-17)	Evaluate the resistance to penetration by impact of small volume of synthetic blood	29 out of 32 pass at 160 mmHg	Passed (32 out of 32 pass at 160 mmHg)
Flammability (16 CFR Part 1610-2008)	Response of materials to heat and flame	Class I	Passed (Class I)
Biocompatibility Evaluation
Cytotoxicity (ISO 10993-5)	Biological Effect	Non-cytotoxic	Passed (Non-cytotoxic)
Sensitization (ISO 10993-10)	Biological Effect	Non-sensitizing	Passed (Non-sensitizing)
Irritation (ISO 10993-10)	Biological Effect	Negligibly irritating	Passed (Negligibly irritating)

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.). It only indicates "Passed" for the results.

The data provenance is from non-clinical tests performed on the "Surgical Face Mask" manufactured by Xiantao Sanda Industrial Co., Ltd. The tests were conducted according to FDA guidance and international standards (ASTM, EN, ISO). The country of origin of the data is implied to be where the manufacturer is located or where the testing was contracted, which is China (Xiantao, Hubei). These are laboratory tests, not human data, so "retrospective or prospective" does not directly apply in the same way it would for clinical studies.

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

This section is not applicable as the ground truth for device performance in this context is established by objective, standardized test methodologies and established acceptance criteria from recognized international standards (ASTM, EN, ISO) and FDA guidance documents. There are no human experts establishing ground truth for these physical and biological performance tests.

4. Adjudication Method for the Test Set

This section is not applicable. The "adjudication method" primarily refers to expert review processes for cases, which is relevant for clinical studies or image-based diagnostic AI. For non-clinical device performance tests like those described (e.g., filtration efficiency, breathability, flammability), the results are quantitative and objective, determined by the test procedures outlined in the standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in the context of AI assistance. This document describes a physical medical device (surgical face mask) with performance evaluated through non-clinical laboratory testing.

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

This section is not applicable. This document describes a physical surgical face mask, not an algorithm or AI-based device. The term "standalone performance" typically refers to the performance of an algorithm without human intervention, which does not apply here.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established scientific and engineering standards and their specified test methodologies. For example:

Bacterial Filtration Efficiency (BFE): Measured according to ASTM F2101, using a biological aerosol of Staphylococcus Aureus. The "ground truth" is the empirically measured percentage of bacteria filtered.
Differential Pressure: Measured according to EN 14683:2019 Annex C, the "ground truth" is the physical measurement of pressure drop across the mask.
Sub-micron Particulate Filtration Efficiency (PFE): Measured according to ASTM F2299-17, using latex spheres. The "ground truth" is the empirically measured percentage of particles filtered.
Resistance to Penetration by Synthetic Blood: Measured according to ASTM F1862-17. The "ground truth" is whether the synthetic blood penetrates the material at a specific pressure.
Flammability: Assessed according to 16 CFR Part 1610-2008. The "ground truth" is the material's flammability classification.
Biocompatibility: Evaluated according to ISO 10993 series (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Sensitization and Irritation). The "ground truth" is the biological response observed in standardized in vitro or in vivo tests.

These tests provide objective, measurable outcomes against predefined criteria.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The performance is assessed through direct physical and biological testing.

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

This section is not applicable for the same reason as point 8; there is no training set mentioned or implied for a physical medical device like a surgical face mask.

Summary

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December 13, 2022

Xiantao Sanda Industrial Co., Ltd % Bryan Wong Associate PureFDA 111 Town Square Place, Suite 1203 Jersey City, New Jersey 07310

Re: K222651

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: November 9, 2022 Received: November 10, 2022

Dear Bryan Wong:

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 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.

Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222651

Device Name Surgical Face Mask

Indications for Use (Describe)

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

Residential Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart G)
-----------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------

__ 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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K222651
1. Date of Submission: October 31, 20220
1. Submitter Identification

XIANTAO SANDA INDUSTRIAL CO., LTD

No.46 Golden Avenue,Xiantao, Hubei, China Establishment Registration Number: 3008048818 Contact Person: Min Rong Position: Technical Manager Tel: 86-728-3221235 Email: info@xtsd.cc

Submission Correspondent: PureFDA Address: 111 Town Square Place, Suite 1203 Jersey City, NJ 07310-2784 Contact Person: Bryan Wong Title: Associate Tel: +1 201-371-3083 Email: bryan@purefda.com

3. Identification of Proposed Device

Trade/Proprietary Name: Surgical Face Mask Common name: Surgical Face Mask

Regulatory Information

Classification Name: Mask, Surgical Classification: Class II Product Code: FXX: Review Panel: Orthopedic

4. Identification of Predicate Device

Predicate Device: 510(k) Number: K221222

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Product Name: Surgical Face Mask (HNFM0304) Manufacturer: Shanghai Hua En Industrial CO LTD

5. Device Description

The Surgical Face Masks are blue color, there-layer, flat-pleaded masks with nose piece and ear loops/ties, which are composed of outer layer, middle layer and inner layer.

The outer layer and inner layer of the mask are made of polypropylene, the middle layer is made of melt-blown polypropylene.

The ear loop/ties of the subject mask is held in place over the users' mouth and nose by two ear loops/ties welded to the face mask. The ear loop is made with polyester and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of high density polyethylene.

The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100 Standard Specification for Performance of Materials Used in Surgical Face Masks.

6. Intended Use Statement

7. Non-clinical Test Conclusion

The Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document,Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has beenperformed.

Test Methodology	Purpose	Acceptance Criteria for Level 3 Barrier	Result
Bacterial FiltrationEfficiencyASTM F2101	Measure bacterial filtrationefficiency	$\geq$ 98%	Passed
Differential Pressure(mmH2O/cm2)EN 14683:2019	Determine breathability ofthe mask	$<$ 6.0 mmH2O/cm2	Passed

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Annex C
Sub-micronParticulateFiltrationEfficiencyASTMF2299-17	Measure initial particlefiltration efficiency	≥98%	Passed
Resistance toPenetrationSynthetic BloodASTM F1862-17	by Evaluate the resistance topenetration by impact ofsmall volume of syntheticblood	29 out of 32 pass at 160 mmHg	Passed
Flammability16 CFR Part1610-2008	Response of materials toheat and flame	Class I	Passed

Biocompatibility Testing

The biocompatibility evaluation for the Surgical Face Mask was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Surgical Face Mask is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.

Biocompatibility Evaluation
	Biological Effect	Standard	Result
1	Cytotoxicity	ISO 10993-5	Non-cytotoxic	Passed
2	Sensitization	ISO 10993-10	Non-sensitizing	Passed
3	Irritation	ISO 10993-10	Negligibly irritating	Passed

8. Summary of Technological Characteristics

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K222651 510(K) Summary

Comparison of Proposed and Predicate Devices
Device	Proposed Device	Predicate Devices	Result
510K #	-	K221222	-
Manufacturer	XIANTAO SANDA INDUSTRIALCO., LTD	SHANGHAI HUA ENINDUSTRIAL COLTD	-
Product Name	Surgical Face Mask	Surgical Face Mask	Same
Level	Level 3	Level 3	Same
Product Code	FXX	FXX	Same
RegulationNumber	21 CFR 878.4040	21 CFR 878.4040	Same
Indicationsforuse	The Surgical Face Mask is intended tobe worn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluidsandparticulate material. The SurgicalFace Mask is intended for use ininfection control practices to reducethe potential exposure to blood andbodyfluids. This a singleuse,disposabledevice(s),providednon-sterile.	The Surgical Face Mask is intendedto be worn to protect both the patientand healthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material. TheSurgical Face Mask is intended foruse in infection control practices toreduce the potential exposure to bloodand body fluids. This a single use,disposable device(s), providednon-sterile.	Same
Design Feature	Ear loop/tie, flat pleated, 3 layers	Ear loops, flat pleated, 4 layers	Different, Note1
Color	Blue	Blue	Same
Dimension	Length: 17.5cm±0.5cmWidth: 9.5±0.5cm	Length: 180±5mmWidth: 95±5mm	Different, Note2
Sterility	Non-sterile	Non-sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
Material
Outer layer	Polypropylene SpunBond Non WovenFabric	spun-bond polypropylene	Same

Second layer	N/A	nylon single way filting net	Different, Note3
Middle layer	Melt-blown Polypropylene Non WovenFabric	melt blown polypropylene	Same
Inner layer	Polypropylene SpunBond Non WovenFabric	spun-bond polypropylene	Same
Nose clip	High Density Polyethylene	polypropylene wrapped aluminium	Different, Note4
Ear loops	Polyester, Spandex	Nylon, spandex	Different, Note5
Biocompatibility	ISO 10993-5 Cytotoxicity:Non-cytotoxic	ISO 10993-5 Cytotoxicity:Non-cytotoxic	Same
	ISO 10993-10 Sensitization:Non-sensitizing	ISO 10993-10 Sensitization:Non-sensitizing
	ISO 10993-10 Irritation: Negligiblyirritating	ISO 10993-10 Irritation: Negligiblyirritating

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Performance Characteristic Comparison
Item	Proposed Device	Predicate Device	ASTM F2100Requirements	Comparison
ASTM F2100 Level	Level 3	Level 3	Level 3	Same
Bacterial FiltrationEfficiency	≥98%	≥98%	≥98%	Same
Differential Pressure(mmH2O/cm2)	<6.0 mmH2O/cm2	<6.0 mmH2O/cm2	<6.0 mmH2O/cm2	Same
Sub-micron ParticulateFiltration Efficiency	≥98%	≥98%	≥98%	Same
Resistance to Penetrationby Synthetic Blood	32 out of 32 pass at160 mmHg	32 out of 32 pass at160 mmHg	29 out of 32 pass at160 mmHg	Same
Flammability	Class I	Class I	Class I	Same

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Note 1:

The different layer number does not raise additional questions for safety and effectiveness. All proposed devices are conducted the test according to ASTM F2100, the test results shown that the proposed device meet the requirements of standard.

Note 2:

The difference in the dimension does not raise additional questions for safety and effectiveness. Proposed devices are conducted the test according to ASTM F2100, the test results shown that the proposed device meet the requirements of standard.

Note 3:

Note 4

The difference in material of nose clip does not raise additional questions for safety and effectiveness. Proposed devices are conducted the biocompatibility best according to ISO 10993, the test results shown that the proposed device meet the requirements of standard.

Note 5:

The difference in material of ear loops does not raise additional questions for safety and effectiveness. Proposed devices are conducted the biocompatibility best according to ISO 10993, the test results shown that the proposed device meet the requirements of standard.

9. Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:

ISO 10993-05:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
A ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization
A ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
A ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic

Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

A EN 14683, Medical Face Masks - Requirements and Test Methods

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ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
ASTM F2299, Standard 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

10. Clinical Test Conclusion

No clinical study is included in this submission.

11. Substantially Equivalent (SE) Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K221222.

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.