The surgical face masks (Ear loops) 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 Face Mask are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.

AI/ML Overview

The provided document (K210222) is a 510(k) premarket notification for a Disposable Medical Mask. This type of device is a Class II medical device, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device (K160269) through performance testing against established standards for medical masks, rather than a clinical study involving human subjects or AI algorithm validation data.

Therefore, many of the requested points, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "training set establishment," etc., are not applicable to this specific submission. The "acceptance criteria" here refer to meeting the performance requirements for physical properties of the mask as per recognized standards (e.g., ASTM F2100-19), not diagnostic accuracy or clinical outcomes assessed by an algorithm.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily derived from standard test methodologies for medical face masks.

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Results)
Level ASTM F2100-19	To define the performances of the medical face mask	Level 1	Level 1
Resistance to penetration by synthetic blood ASTM F1862	To evaluate the resistance of medical face masks to penetration by the impact of a small volume of high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.	Minimum 80mmHg	Pass at 80mmHg
Particulate Filtration Efficiency ASTM F2299	To measure the initial particle filtration efficiency of materials used in medical face mask using monodispersed polystyrene latex sphere aerosols.	≥95%	Pass at 98.33%
BFE ASTM F2101	To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.	≥95%	Pass at 99.99%
Differential Pressure EN 14683:2019+AC:2019 AnnexC	To determine the breathability of medical face mask by measuring the differential air pressure with the airflow direction from the inside of the mask to the outside of the mask.	<5.0mmHg	Pass at 4.1 mmH2O/cm2
Flammability 16 CFR 1610	To measure the response of materials, products, or assemblies to heat and flame.	Class 1	Class 1
Cytotoxicity	To determine the potential of a test article to cause cytotoxicity	Non-cytotoxic	Non-cytotoxic
Irritation test	To evaluate the test article for the potential to cause skin irritation in the rabbit.	Non-irritation	Non-irritation
Sensitization test	To evaluate the potential of the test articles to cause delayed dermal contact sensitization in the guinea pig maximization test.	Non-sensitization	Non-sensitization

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of masks) used for each individual performance test (e.g., how many masks were tested for BFE). However, these are standard laboratory tests typically performed on a statistically relevant sample size of units from a production batch to ensure consistency. The provenance of the data is from non-clinical laboratory testing, likely conducted in China, as the manufacturer is based in China. The testing is retrospective in the sense that it's performed on manufactured samples for regulatory submission. It is not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for the performance tests of a medical mask (e.g., BFE, PFE, fluid resistance) is established by the standardized test methodologies themselves and the physical measurements obtained. It does not involve expert readers or clinical interpretation like in diagnostic AI.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication step in these physical performance tests.

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 physical medical device (mask), not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device, which is a physical barrier, is defined by its measured physical performance characteristics as specified by internationally recognized standards (e.g., ASTM F2100-19, EN 14683). This includes:

Bacterial Filtration Efficiency (BFE)
Particulate Filtration Efficiency (PFE)
Fluid Resistance
Differential Pressure (Breathability)
Flammability
Biocompatibility (Cytotoxicity, Irritation, Sensitization)

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Summary

{0}------------------------------------------------

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.

November 2, 2021

Guangdong Lide Medical Technology Co., Ltd. % Ying Hou Consultant Microkn Business Consulting (Shanghai) Co., Ltd Room 1215, Block A, No 3699, Gonghexin Road, Jingan District Shanghai. 200435 China

Re: K210222

Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: September 5, 2021 Received: September 22, 2021

Dear Ying Hou:

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

{1}------------------------------------------------

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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210222

Device Name Disposable Medical Mask

Indications for Use (Describe)

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

✘ Prescription Use (Part 21 CER 801 Subpart D)
□ Over-The-Counter Use (21 CER 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510K Summary

According to the requirements Per 21 CFR §807.92:

Company:	Guangdong Lide Medical Technology Co.,Ltd.
Address:	HFDB-05-2102 Ecological Technology City, West Side of Haizi Road,Chengdong Town, Haifeng County, Shanwei City516400, GuangdongProvince, China
Contact Person:	Zhuang ShenglinTelephone: 18664514268E-mail: 158953590@qq.com
Common Name	Disposable Medical Mask
ClassificationName:	21 CFR 878.4040
LegalManufacturer:	Guangdong Lide Medical Technology Co.,Ltd.HFDB-05-2102 Ecological Technology City, West Side of Haizi Road,Chengdong Town, Haifeng County, Shanwei City516400, GuangdongProvince, China
Predicate Device
Predicate Device:	Surgical Face Masks (Ear loops and Tie-on)
510(k) Number:	K160269
Consultant
Company	Microkn Business Consulting (Shanghai) Co., Ltd.
Address	Room 1219, Block A, No 3699, Gonghexin Road, Jingan District,Shanghai, China
Contact Person	Yuling Chen
Telephone	+86 15021397762
Email	Yuling.chen@microkn.com

{4}------------------------------------------------

1. Indications for use

2. Description of the Device

Image /page/4/Figure/4 description: The image shows a technical drawing of a face mask. The drawing includes two views of the mask, one from the front and one in perspective. The front view shows the length (L) and height (H) of the mask. The perspective view shows the different layers of the mask, including the spunbond layer, melt spraying layer, and nose clip. The mask belt is also labeled.

Figure. 1 Structure

3. Sizes of the product

The sizes of the product shown in Table 1.

{5}------------------------------------------------

Table 1 The sizes of the product

Model	Size (mm)		layers
	Length(L)	Width(H)
Earloop style175×95	$175\pm5%$	$95\pm5%$	3

4. Components

The main components of proposed device are shown in Table 2.

Components	Function Description	Applied Model(s)
Outer Spunbond layer	Block water and prevent droplets from entering the mask	All Models
Components	Function Description	Applied Model(s)
Meltblown layer	Filter	All Models
Inner Spunbond layer	moisture absorption	All Models
Nose clip	fixed geometry	All Models
Mask belt	secure the mask over the user's face and mouth	All Models

Table 2 Main Components of Proposed Device

5. Technological Characteristics Comparison to Predicate Device

Feature	Proposed Device	Predicate device
510(K)#	K210222	K160269 (EL 10000)
Level	Level 1	Level 1
Manufacturer	Guangdong Lide MedicalTechnology Co.,Ltd.	San-M Package Co.,Ltd.
Common Name	Surgical Mask	Surgical Mask
Classification	Class II	Class II
Product Code	FXX	FXX
Feature	Proposed Device	Predicate device
Intended Use	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.	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 devices are intended for use in infection control practices to reduce the patient exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Materials
Outer Material	Polypropylene	Polypropylene
Inner Material	Polypropylene spunbondPolypropylene meltblown	Polypropylene spunbondPolypropylene meltblown
Ear Loops/mask belt	Nylon and Spandex	Polyester, polyuretha ne, polyester spunbond
Colorant	White (Inner) and blue (Outer side)	White (Inner) and blue (Outer side)
Specifications	Length:175mm±5mmWidth:95mm±5mm	Length:90±3mmLength:90+3mm
Feature	Proposed Device	Predicate device
		Width:175±5mm	Width:185mm
Mask Style	Flat-pleated	Flat-pleated
Sterility	Non-sterile	No- sterilization
PerformanceTesting(ASTM F2100-19)	Level 1	Level 1
BFE	Pass at 99.99%	Pass at 99.6%
ParticulateFiltratinEfficiency	Pass at 98.33	Pass at >98%
DifferentialPressure	Pass at 4.1 mmH2O/cm2	Pass at 2.0 mmH2O/cm2
Resistance topenetration byblood	Pass at 80mmHg	Pass at 80mmHg
Flammability	Class 1	Class 1
BiocompatibilityContact Category	Skin	Skin
BiocompatibilityContact Duration	Prolong	Prolong
Shelf life	1 year	Unavailable frompublic information(Difference 1)

{6}------------------------------------------------

{7}------------------------------------------------

Difference 1: Real-time aging testing was carried out to decide the shelf life of the proposed surgical mask. Testing results demonstrated that the life of the surgical mask is 1 years. The difference will not generate negative affect for the safety and performance of the device used following the IFU.

{8}------------------------------------------------

6. Summary of Non-Clinical Test Data

The following nonclinical testing was performed to demonstrate the subject device conform to the standard or test methodology found in the summary table below. The results demonstrate the subject device met the acceptance criteria or specifications described below.

6.1 Animal Study

None

6.2 Performance Study

Test Methodology	Purpose	Acceptance Criteria	Results
LevelASTM F2100-19	To define theperformances of themedical face mask	Level 1	Level 1
Resistance topenetration bysysthetic bloodASTM F1862	To evaluate the resistanceof medical face masks topenetration by the impactof a small volume ofhigh-velocity stream ofsynthetic blood. Medicalface mask pass/faildeterminations are basedon visual detection ofsynthetic bloodpenetration.	Minimum 80mmHg	Pass at 80mmHg
Particulate FiltrationEfficiencyASTM F2299	To measure the initialparticle filtratioonefficiency of materialsused in medical facemask usingmonodispersedpolystyrene latex sphereaerosols.	≥95%	Pass at 98.33%
BFE ASTM F2101	To measure the bacterialfiltration efficiency(BFE) of medical facemask materials,employing a ratio of theupstream bacterialchallenge to downstreamresidual concentration to	≥95%	Pass at 99.99%
Test Methodology	Purpose	Acceptance Criteria	Results
	determine filtrationefficiency of medical facemask materials
Differential PressureEN14683:2019+AC:2019AnnexC	To determine thebreathability of medicalface mask by measuringthe differential airpressure with the airflowdirection from the insideof the mask to the outsideof the mask.	<5.0mmHg	Pass at 4.1mmH2O/cm2
Flammability16 CFR 1610	To measure the responseof materials, products, orassemblies to heat andflame.	Class 1	Class 1
Cytotoxicity	The purpose of this studywas to determine thepotential of a test article tocause cytotoxicity	Non-cytotoxic	Non-cytotoxic
Irritation test	The purpose of this studywas to evaluate the testarticle for the potential tocause skin irritation in therabbit.	Non-irritation	Non-irritation
Sensitization test	The purpose of this studywas to evaluate thepotential of the test articlesto cause delayed dermalcontact sensitization in theguinea pig maximizationtest.	Non-sensitization	Non-sensitization

{9}------------------------------------------------

7. 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 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.