The Disposable 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(s), provided non-sterile.

Device Description

The Disposable Surgical Face Mask is blue color, single use, that-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.

The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of galvanized iron wire coated by polypropylene (PP), ear loop is made of Nylon and Spandex, and the ties are made of polypropylene spun-bond nonwoven fabric.

The size of surgical face masks is 17.5*9.5cm with tolerance±5%, the length of the ear loop is about 15.5cm to 16.5cm, and the length of the ties is 40 cm.

The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided document is a 510(k) summary for a Disposable Surgical Face Mask. This type of medical device is generally subject to performance testing against established standards, rather than clinical studies requiring expert interpretation or AI/algorithm performance. Therefore, many of the requested elements (like MRMC studies, details on experts, ground truth for training sets, etc.) are not applicable to this specific device submission.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-powered, non-software-driven medical device (disposable surgical face mask). Its performance is evaluated against recognized industry standards for surgical masks.

Test Methodology	Purpose	Acceptance Criteria (ASTM F2100 Level 3)	Reported Device Performance
Fluid Resistance (ASTM F1862)	To assess resistance to penetration by synthetic blood.	29 out of 32 pass at 160 mmHg for level 3	Pass: 32 out of 32 pass at 160 mmHg, 3 lots
Particulate Filtration Efficiency (ASTM F2299)	To demonstrate functionality and efficiency of materials in filtering particulates.	≥ 98%	Pass: Average 99.1%
Bacterial Filtration Efficiency (ASTM F2101)	To demonstrate functionality and efficiency in filtering bacteria.	≥ 98%	Pass: Average 99.5%
Differential Pressure (EN 14683 Annex C)	To measure breathability.	< 6.0 mmH2O/cm²	Pass: Average 3.4 mmH2O/cm²
Flammability (16 CFR 1610)	To assess the flammability of the material.	Class 1	Pass: Class 1
Cytotoxicity (ISO 10993-5)	To demonstrate the safety of the subject device (biological evaluation).	Non-cytotoxic	Pass: Under the conditions of the study, the device is non-cytotoxic.
Irritation (ISO 10993-10)	To demonstrate the safety of the subject device (biological evaluation).	Non-irritating	Pass: Under the conditions of the study, the device is non-irritating.
Sensitization (ISO 10993-10)	To demonstrate the safety of the subject device (biological evaluation).	Non-sensitizing	Pass: Under the conditions of the study, the device is non-sensitizing.

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

Fluid Resistance: 3 lots of devices were tested, with the acceptance criteria referencing "29 out of 32 passes", implying a sample size of at least 32 masks per test lot.
Other Performance Tests (Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): The specific sample sizes for these tests are not detailed beyond "Average 99.1%", "Average 99.5%", "Average 3.4mmH2O/cm²", and "Class 1", which usually indicates an average or singular result from a batch of samples tested according to the respective standards.
Biocompatibility Tests (Cytotoxicity, Irritation, Sensitization): These tests are performed on extracts from the device material according to ISO 10993 standards. Specific sample sizes for the biological assays are not provided, but the conclusions ("non-cytotoxic," "non-irritating," "non-sensitizing") reflect the results from the required in-vitro or in-vivo tests.

Data Provenance: The tests were conducted as "Non-clinical tests" to verify that the proposed device met design specifications for the standards and test methods. The origin of the testing (e.g., country of actual lab) is not specified, but the applicant (FOMED INDUSTRIES INC.) is based in China. These are prospective tests performed specifically for device clearance.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The device is a surgical mask, and its performance is evaluated through standardized laboratory tests, not by human experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. Performance is determined by objective physical and biological test results against defined numerical and qualitative criteria in recognized standards, not by expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was done as the device is not an AI-assisted diagnostic or triaging tool.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical product (face mask), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device is based on established industry standards and test methodologies for medical face masks and biocompatibility, such as ASTM F2100, F1862, F2299, F2101, EN 14683, 16 CFR 1610, and ISO 10993. These standards define the acceptable performance limits for each characteristic.

8. Sample Size for the Training Set

Not applicable. This is a physical non-software medical device, so there is no "training set" in the context of machine learning or algorithms. The manufacturing process is subject to quality control, but this is distinct from training data for an algorithm.

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

Not applicable. As there is no training set for an algorithm, this question is not relevant. The device manufacturer adheres to Good Manufacturing Practices (GMP) and ISO 13485 standards for quality management during production, ensuring consistency with the tested samples.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

April 25, 2022

Fomed Industries Inc. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai. 200122 China

Re: K220512

Trade/Device Name: Disposable Surgical Face Mask (M01, M02) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 22, 2022 Received: February 22, 2022

Dear Ivy Wang:

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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220512

Device Name Disposable Surgical Face Mask (M01, M02)

Indications for Use (Describe)

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

Depository Use (Part 264 CFR 801 Subpart D)	On-Site Combustion (264 CFR 801 Subpart O)
----------------------------------------------------------------------	--------------------------------------------------------------------------------

__ 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

Prepared date: 2022-02-12 A. Applicant: FOMED INDUSTRIES INC. Address: 20 HAN SHA ROAD. HOUHU DISTRICT QIANJIANG CITY, HUBEI PROVINCE. CHINA 433115 Contact Person: Xing He Tel: +8613869469536 Email: qara@fomed.cn

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Disposable Surgical Face Mask Common Name: Disposable Surgical Mask Model: Ear-loop, Tie-on

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

C. Predicate device: (Primary)

K210433 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.

D. Indications use of the device:

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E. Device Description:

The Disposable Surgical Face Mask is blue color, single use, that-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.

The size of surgical face masks is 17.5*9.5cm with tolerance±5%, the length of the ear loop is about 15.5cm to 16.5cm, and the length of the ties is 40 cm.

The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

Device	Proposed Device	Predicate Device	Result
Manufacturer	FOMED INDUSTRIES INC.	Wuhan Dymex Healthcare Co.,Ltd.	-
510K number	-	K210433	-
Model name	Disposable Surgical Face Mask	Surgical Face Mask	Same
Classification	Class II Device, FXX (21CFR878.4040)	Class II Device, FXX (21CFR878.4040)	Same
Intended use	The Disposable Surgical FaceMasks are intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material.These face masks are intendedfor use in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s), providednon-sterile.	The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Theseface masks are intended for usein infection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile.	Same
Model	Ear loop, Tie-on, Flat pleated,3layers	Ear loop, Tie-on, Flat pleated,3layers	Same
Material	Outerlayer	Spun-bond polypropylenenonwoven fabric	Spun-bond polypropylene	Same
	Middlelayer	Melt blown polypropylenenon-woven fabric	Melt-blown Polypropylene	Same

F. Comparison with predicate device

Table 1 General Comparison

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FOMED INDUSTRIES INC.
20 HAN SHA ROAD, HOUHU DISTRICT QIANJIANG CITY, HUBEI PROVINCE, CHINA
433115

	Inner layer	Spun-bond polypropylene nonwoven fabric	Spun-bond polypropylene	Same
	Nose clip	Galvanized iron wire coated by polypropylene (PP)	Malleable polyethylene wire	Different
Ear loops		Nylon, Spandex	Spandex	Different
	Ties	Spun-bond polypropylene nonwoven fabric	Spunbond Polypropylene	Same
Color		Blue	Blue	Same
	Dimension (Length)	17.5cm+/-5%	17.5cm+/-0.2cm	Similar
	Dimension (Width)	9.5cm+/-5%	9.5cm+/-0.2cm	Similar
	OTC use	Yes	Yes	Same
	Sterility	Non-Sterile	Non-Sterile	Same
	Use	Single Use, Disposable	Single Use, Disposable	Same
	ASTM F2100 level	Level 3	Level 3	Same
	Fluid Resistance Performance ASTM F1862	32 out of 32 pass at 160 mmHg	32 out of 32 pass at 160 mmHg	Same
	Particulate Filtration Efficiency ASTM F2299	$\geq 98%$	$\geq 98%$	Same
	Bacterial Filtration Efficiency ASTM F2101	$\geq 98%$	$\geq 98%$	Same
	Differential Pressure (Delta P) EN 14683 Annex C	< 6.0mmH2O/cm²	< 6.0mmH2O/cm²	Same
	Flammability 16 CFR 1610 16	Class 1	Class 1	Same
	Biocompatibility	ISO10993	ISO10993	Same

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specification for the standards and test methods. 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 Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:

A 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 A Skin Sensitization
ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks

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FOMED INDUSTRIES INC. 20 HAN SHA ROAD, HOUHU DISTRICT QIANJIANG CITY, HUBEI PROVINCE, CHINA

433115

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);
EN 14683, Medical Face Masks-Requirements and Test Methods;
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, 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;

Test Methodology	Purpose	Acceptance Criteria:ASTM F2100 Level 3	Result
Fluid Resistance		29 out of 32 pass at160 mmHg for level 3	Pass32 out of 32 pass at 160mmHg, 3 lots
ParticulateFiltrationEfficiency	The purpose ofthe performancetesting is todemonstrate thefunctionality ofthe subjectdevice.	≥ 98%	PassAverage 99.1%
Bacterial FiltrationEfficiency		≥ 98%	PassAverage 99.5%
DifferentialPressure		< 6.0mmH2O/cm²	PassAverage 3.4mmH2O/cm²
Flammability		Class 1	Pass, Class 1
Cytotoxicity	The purpose ofthe testing is todemonstrate thesafety of thesubject device.	Non-cytotoxic	Under the conditions ofthe study, the device isnon-cytotoxic.
Irritation		Non-irritating	Under the conditions ofthe study, the device isnon-irritating.
Sensitization		Non-sensitizing	Under the conditions ofthe study, the device isnon-sensitizing

Table 2 - Performance Testing & Biocompatibility

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusions 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 predicate device K210433.

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.