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 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 proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Face 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 model of proposed device, YX011, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.

The model of proposed device, YX121, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.

The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene and iron.

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

AI/ML Overview

This document is a 510(k) summary for a "Surgical Face Mask" (Trade Name) from Hunan EEXI Technology & Service Co., Ltd. It's a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, this document does not describe the acceptance criteria and the study that proves an AI/algorithm-based device meets acceptance criteria. It discusses the performance criteria for a physical medical device (a surgical face mask).

The request asks about aspects of an AI/algorithm study (e.g., sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment). These concepts are not applicable to the evaluation of a physical surgical face mask as described in this 510(k) submission.

However, I can extract the acceptance criteria and reported device performance for the Surgical Face Mask based on the provided text, and explain why other aspects of your question are not relevant here.

Acceptance Criteria and Reported Device Performance (for the Surgical Face Mask)

The acceptance criteria for this medical device are based on the ASTM F2100-19 standard for the "Performance of Materials Used in Medical Face Masks" and ISO 10993-1 for biocompatibility. The device is intended to meet Level 3 performance based on ASTM F2100.

Here's a table summarizing the performance standards (acceptance criteria) and the reported performance of the subject device (Surgical Face Mask, K202161) and comparison to its predicate device (K153496):

Table of Acceptance Criteria and Reported Device Performance

Performance Test / Characteristic	Acceptance Criteria (Target for Subject Device)	Reported Device Performance (Subject Device K202161)	Predicate Device Performance (K153496)	Comments to Predicate
Material/Design
Product Name	Surgical Face Mask	Surgical Face Mask	Disposable Surgical Face Mask	Similar
Product Code	FXX	FXX	FXX	Same
Regulation Number	21 CFR § 878.4040	21 CFR § 878.4040	21 CFR § 878.4040	Same
Classification	Class II	Class II	Class II	Same
OTC use	Yes	Yes	Yes	Same
Intended Use	As described in section 6	As described in section 6	Similar to subject device	Same
Design Feature	Ear-loop, Tie-on	Ear-loop, Tie-on	Ear-loop, Tie-on	Same
Usage	Single use	Single use	Single use	Same
Color	Blue	Blue	Blue	Same
Size	(175±10) mm×(95±10)mm	(175±10) mm×(95±10)mm	(17.5±1) cm×(9.5±1)cm	Same (unit conversion)
Sterile	Non-sterile	Non-sterile	Non-sterile	Same
Material (Outer Layer)	Spun-bond polypropylene	Spun-bond polypropylene	Spun-bond polypropylene	Same
Material (Middle Layer)	Melt blown polypropylene filter	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
Material (Inner Layer)	Spun-bond polypropylene	Spun-bond polypropylene	Spun-bond polypropylene	Same
Nose piece	Polyethylene and iron	Polyethylene and iron	Malleable aluminum wire	Similar
Ear-loops	Elastic fiber	Elastic fiber	Polyester	Similar
Tie-on	Spun-bond polypropylene	Spun-bond polypropylene	Spun-bond polypropylene	Same
Performance (ASTM F2100)	Level 3 Requirements	Meets Level 3 Classification	Meets Level 2 Classification	Subject device meets higher level
Fluid Resistance (ASTM F1862-13)	Meets Level 3	Met Level 3 Requirements	Met Level 2 Requirements	Similar (higher performance)
Particulate Filtration Efficiency (ASTM F2299)	Meets Level 3	Met Level 3 Requirements	Met Level 2 Requirements	Similar (higher performance)
Bacterial Filtration Efficiency (ASTM F2101)	Meets Level 3	Met Level 3 Requirements	Met Level 2 Requirements	Similar (higher performance)
Differential Pressure (EN 14683:2019+AC:2019)	Meets Level 3	Met Level 3 Requirements	Met Level 2 Requirements	Similar (higher performance)
Flammability (16CFR 1610)	Class 1	Class 1	Class 1	Same
Biocompatibility (ISO 10993)
Cytotoxicity	Non cytotoxic (ISO 10993-5)	Non cytotoxic	Non cytotoxic	Same
Irritation	Non irritating (ISO 10993-10)	Non irritating	Non irritating	Same
Sensitization	Non sensitizing (ISO 10993-10)	Non sensitizing	Non sensitizing	Same

Response to AI/Algorithm-Specific Questions (Not Applicable to this document)

The following points are pertinent to AI/algorithm-based devices but are not discussed or applicable in this 510(k) submission for a physical surgical face mask. This document focuses on material properties, physical dimensions, and established performance standards for protective apparel.

Sample sizes used for the test set and the data provenance: Not applicable. Tests are conducted on physical samples of the face mask, not a 'test set' of data in the AI sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance is measured objectively through standardized laboratory tests (e.g., measuring particulate filtration). Ground truth is established by the test method's result, not expert consensus.
Adjudication method: Not applicable. No human interpretation or adjudication as in AI model evaluation.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted human reading, not for a physical mask.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. No algorithm is involved.
The type of ground truth used: For physical masks, "ground truth" is typically defined by the results of the standardized physical and material tests (e.g., a certain percentage of particles were blocked, a certain fluid penetration resistance was achieved).
The sample size for the training set: Not applicable. There is no 'training set' as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (surgical face mask) and its evaluation against established performance standards for such products. It does not pertain to the development or validation of an AI/algorithm-based medical device.

Summary

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March 10, 2021

Hunan EEXI Technology & Service Co., Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co.,Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China

Re: K202161

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 16, 2021 Received: February 8, 2021

Dear Joyce Yang:

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.

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202161

Device Name Surgical Face 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 K202161

This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.

1. Submission Sponsor

Applicant Name	Hunan EEXI Technology & Service Co.,Ltd.
Address	No. 6 North of Pingtou Road, Liuyang Hi-techIndustrial Development Zone, Hunan China.
Contact person	Zhang Xianliang
Phone	+0086-15874115252

Submission correspondent 2.

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen
Post Code	518000
Phone No.	+86-755-86069197
Contact Person	Joyce Yang
Email	joyce@cefda.com

3. Devices Identification

Type of 510(k) submission	Traditional
Trade Name	Surgical Face Mask
Model	YX011, YX121
Classification name	Mask, Surgical
Review Panel	Surgical Apparel
Product Code	FXX
Device Class	II
Regulation Number	878.4040

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4. Legally Marketed Predicate Devices
Trade Name	Disposable Surgical Face Mask
Regulation number	878.4040
Regulation class	II
Regulation name	Surgical Apparel
510(k) Number	K153496
Product Code	FXX
Manufacturer	Xiantao Rayxin Medical Products Co.,Ltd.

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Device Description 5.

The model of proposed device, YX011, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.

The model of proposed device, YX121, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.

The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene and iron.

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

6. Intended Use/ Indications for Use

7. Technological characteristics of the subject device compared to the predicate device

7.1 Predicate Device Information:

510(K) No.:	K153496
Common name:	Disposable Surgical Face Mask
Classification name:	Mask, Surgical

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Production regulation: 21 CFR § 878.4040 Product code: FXX

Panel: Surgical Apparel

7.2 Comparison to predicate device:

Comparisonitem	Subject Device(K202161)	Predicate Device(K153496)	Comments
Applicant	Hunan EEXI Technology &Service Co.,Ltd.	Xiantao Rayxin MedicalProducts Co.,Ltd.
Productname	Surgical Face Mask	Disposable Surgical FaceMask	Similar
ProductCode	FXX	FXX	Same
RegulationNumber	21 CFR § 878.4040	21 CFR § 878.4040	Same
Classification	Class II	Class II	Same
OTC use	Yes	Yes	Same
Intendeduse &Indications for Use	The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. This isa single use, disposabledevice, provided non-sterile.	The Disposable SurgicalMasks are intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a singleuse, disposable device,provided non-sterile.	Same
Designfeature	Ear-loop, Tie-on	Ear-loop, Tie-on	Same
Usage	Single use	Single use	Same
Color	Blue	Blue	Same
Size	(175±10) mm×(95±10)mm	(17.5±1) cm×(9.5±1)cm	Same
Sterile	Non-sterile	Non-sterile	Same
Material	Outer layer: Spun-bondpolypropylene	Outer layer: Spun-bondpolypropylene	Same
	Middle layer: Melt blownpolypropylene filter	Middle layer: Melt blownpolypropylene filter	Same
	Inner layer: Spun-bondpolypropylene	Inner layer:Spun-bondpolypropylene	Same
	Nose piece: polyethyleneand iron	Nose piece:Malleablealuminum wire	Similar
	Ear-loops: Elastic fiber	Ear-loops:Polyester	Similar
	Tie-on:Spun-bondpolypropylene	Tie-on:Spun-bondpolypropylene	Same
ASTM F2100 Level	Level 3	Level 2	Similar
FluidResistancePerformanceASTM F1862-13	Meet the ASTM F2100Requirements for Level 3Classification	Meet the ASTM F2100Requirements for Level 2Classification	Similar
ParticulateFiltrationEfficiencyASTM F2299	Meet the ASTM F2100Requirements for Level 3Classification	Meet the ASTM F2100Requirements for Level 2Classification	Similar
BacterialFiltrationEfficiencyASTM F2101	Meet the ASTM F2100Requirements for Level 3Classification	Meet the ASTM F2100Requirements for Level 2Classification	Similar
DifferentialPressure(Delta P) EN14683:2019+AC:2019	Meet the ASTM F2100Requirements for Level 3Classification	Meet the ASTM F2100Requirements for Level 2Classification	Similar
Flammability16CFR 1610	Class 1	Class 1	Same
Cytotoxicity	Comply with ISO 10993-5Non cytotoxic	Comply with ISO 10993-5Non cytotoxic	Same
Irritation	Comply with ISO 10993-10Non irritating	Comply with ISO 10993-10Non irritating	Same
Sensitization	Comply with ISO 10993-10Non sensitizing	Comply with ISO 10993-10Non sensitizing	Same

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Non-clinical Testing 8.

Surgical Face Mask conforms to the following standards:

ASTM F 2100-19, Standard Specification for Performance of Materials Use in . Medical Face Masks.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices Part 1: ● Evaluation And Testing Within A Risk Management Process.

Bench testing

The bench testing of Surgical Face Mask include the following tests:

*Fluid Resistance Performance
*Particulate Filtration Efficiency
*Bacterial Filtration Efficiency
*Differential Pressure
*Flammability

Biocompatibility testing

The biocompatibility evaluations were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The tests of Surgical Face Mask include the following tests:

- Cytotoxicity
- Sensitization
- Irritation

9. Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.

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.