The Surgical Mask is 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 Surgical Mask is a single use, Flat Pleated mask with ear loops and nose piece. The Surgical Mask is consisting of three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The Surgical Mask uses different colors to distinguish the inner and outer layers, the inner layer is white and the outer layer is blue. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire. The Surgical Mask is sold non-sterile and is intended to be single use, disposable devices.

AI/ML Overview

This document describes the premarket notification (510(k)) for a Surgical Mask (K201852) and its substantial equivalence to a predicate device (K182515). The information provided focuses on non-clinical performance testing to demonstrate this equivalence. Since this is a submission for a Surgical Mask, the "device" in the context of your request refers to the surgical mask itself, not an AI or software-based medical device.

Therefore, many of the questions you've asked, which are typically relevant for AI/ML-based medical devices, are not applicable to this submission. This document does not describe an AI/ML device that requires a test set, ground truth established by experts, MRMC studies, or training sets.

Here's an analysis based on the provided document:

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

Performance Characteristics	Test Method	Acceptance Criteria	Test Result
Fluid Resistance Performance	ASTM F1862/F1862M-17	29 out of 32 passes at 120mmHg	32 out of 32 passes at 120mmHg
Particulate Filtration Efficiency	ASTM F2299/F2299M-03	≥98%	99.79%
Bacterial Filtration Efficiency	ASTM F2101-19	≥98%	99.70%
Differential Pressure (ΔΡ)	MIL-M-36954C	<6.0mmH2O/cm²	3.813 mm H2O/cm²
Flammability	16 CFR 1610	Class 1	Class 1
Cytotoxicity	ISO 10993-5:2009	Under the conditions of the study, the device is non-cytotoxic.	Non-cytotoxic
Irritation	ISO 10993-10:2010	Under the conditions of the study, the device is non-irritating.	Non-irritating
Sensitization	ISO 10993-10:2010	Under the conditions of the study, the device is non-sensitizing	Non-sensitizing

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

Sample sizes for test set:
- Fluid Resistance: 32 samples (implied by "32 out of 32 passes").
- Other tests (Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability, Biocompatibility): The exact sample size for each test is not explicitly stated, but tests were conducted. These are material/product performance tests, not "data provenance" in the AI/ML sense.
Data Provenance: Not applicable in the context of a surgical mask. The tests are non-clinical laboratory tests performed on the physical device. The manufacturing country is China.

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 physical device (surgical mask) and its performance is evaluated through standardized non-clinical laboratory tests, not by expert review of data for ground truth establishment, as would be the case for an AI/ML device.

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

Not Applicable. See point 3.

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

Not Applicable. This is a surgical mask, not an AI-assisted diagnostic tool. No human reader studies were performed or are relevant.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable. The "ground truth" for a surgical mask's performance is defined by the standardized test methods (e.g., ASTM F1862 for fluid resistance) and the associated physical measurements. There isn't a "ground truth" in the diagnostic or AI sense.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not Applicable. See point 8.

Summary

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March 2, 2021

Huizhou Foryou Medical Devices Co., Ltd Guosheng Tan Development Engineer No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou, Guangdong 516005 China

Re: K201852

Trade/Device Name: Surgical Mask-Model Number: Ear Loop, Flat-Pleated Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 27, 2021 Received: February 1, 2021

Dear Guosheng Tan:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 mediation-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 Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: 0MB No. 0910-0120 Expiration Date: 0613012020 See PRA Statement below.

510(k) Number (if known) K201852

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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FORM FDA 3881 (7117)

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510(k) Summary

This 510(k) Summary information is being submitted in accordance with the requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K201852

1. Submitter:

Huizhou Foryou Medical Devices Co., Ltd.

Address:	No.1 Shangxia North Road, Dongjiang Hi-tech IndustryPark, Huizhou, Guangdong, China
Phone:	+86-0752-5302185
Fax:	+86-0752-5302020
Contact Person:	Guosheng Tan
Date Prepared:	March 2, 2021

Subject Device:

Trade Name:	Surgical Mask
Common Name:	Surgical Mask
Classification Name:	Mask, Surgical
Review Panel:	General Hospital
Product Code:	FXX
Regulation Number:	21 CFR §878.4040
Device Class:	Class II

1. Predicate Device:
  K182515

Surgical Face Mask

Wuhan Dymex Healthcare Co., Ltd

Page 1 of 4

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4. Device Description:

5. Indications for Use:

6. Technological Characteristics Comparison

Table 5.1 Comparison of technological characteristics between subject device

Item	Subject Device(K201852)	Predicate Device(K182515)	Comparison
Intended Use	The Surgical Mask isintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, body	The Surgical Face Masksare intended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, body	Same

and predicate device

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	fluids and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile.	fluids and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is a singleuse, disposable device(s),provided non-sterile.
Model	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Flat Pleated, 3 layers	Same
Material	Outer layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Middle layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
	Inner layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
Nosepiece	Malleable polypropyleneand metal wire	Malleable polyethylenewire	Similar
Ear loops	Spandex	Spandex	Same
Color	Blue/White	Yellow	Different*
Dimension	Length	$17.5cm \pm 1cm$	$17.5cm \pm 0.2cm$	Same
	Width	$9.5cm \pm 1cm$	$9.5cm \pm 0.2cm$	Same
Sterility		Non-Sterile	Non-Sterile	Same
Use		Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100 Level		Level 2	Level 2	Same

*The difference in the color does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all color additives.

7. Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the subject device met all design specifications as the predicate device. The test results demonstrate that the subject device conforms to the recognized standards ASTM F2100-19, ISO 10993-5 and ISO 10993-10 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notification [510(k)] Submission issued on March 5, 2004. Detailed test results are shown in the table 5.2.

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PerformanceCharacteristics	Test Method	Acceptance Criteria	Test Result
Fluid ResistancePerformance	ASTM F1862/F1862M-17	29 out of 32 passes at120mmHg	32 out of 32 passes at120mmHg
ParticulateFiltrationEfficiency	ASTM F2299/F2299M-03	≥98%	99.79%
Bacterial FiltrationEfficiency	ASTM F2101-19	≥98%	99.70%
DifferentialPressure (ΔΡ)	MIL-M-36954C	<6.0mmH2O/cm²	3.813 mm H2O/cm²
Flammability	16 CFR 1610	Class 1	Class 1
Cytotoxicity	ISO 10993-5:2009	Under the conditions ofthe study, the device isnon-cytotoxic.	Non-cytotoxic
Irritation	ISO 10993-10:2010	Under the conditions ofthe study, the device isnon-irritating.	Non-irritating
Sensitization	ISO 10993-10:2010	Under the conditions ofthe study, the device isnon-sensitizing	Non-sensitizing

Table 5.2 Summary of Non-clinical Performance Testing

8. Clinical Performance Test

No clinical study is included in this submission.

9. 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 K182515, Surgical Face Mask, Wuhan Dymex Healthcare Co., Ltd.

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.