The device 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 Medical disposable face mask non sterile is single use, three-layer, flat-folded masks with ear loops and nose piece. The Medical disposable face mask non sterile is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The outer non-woven cloth is blue and is dyed by colorant of Reactive Blue 2, and the inner non-woven cloth is white and is not dyed by colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Medical disposable face mask non sterile will be provided in blue. The Medical disposable face mask non sterile is sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria	Reported Device Performance
Fluid Resistance ASTM F1862	29 out of 32 pass at 120mmHg	3 batches, synthetic blood penetration of 32 test articles per each batch is none seen at 120mmHg test pressure. (This means 32 out of 32 passed for each of the 3 batches, exceeding the 29 out of 32 acceptance criteria)
Particulate Filtration Efficiency ASTM F2299	Level 2 ≥ 98%	3 batches, average PFE of 32 test articles per each batch: >99.986%, >99.986%, >99.982%; standard deviation: 0.0123, 0.0142, 0.0389. (All results are significantly higher than the 98% acceptance criteria.)
Bacterial Filtration Efficiency ASTM F2101	Level 2 ≥ 98%	3 batches, BFE of 32 test articles per each batch: >99.9%, >99.9%, >99.9%. (All results are significantly higher than the 98% acceptance criteria.)
Differential Pressure (Delta P) EN 14683:2019+AC:2019 Annex C, Flow rate 8 L/min	Level 2 < 6.0mmH2O/cm²	3 batches, Delta P of 32 test articles per each batch: 2.7-3.2 mmH2O/cm², 2.7-2.9 mmH2O/cm², 2.6-3.0mmH2O/cm². (All results are well below the 6.0mmH2O/cm² acceptance criteria.)
Flammability 16 CFR 1610	Class 1	Class 1 (3 batches, 32 test articles per each batch are ignited, but extinguished). (Meets the Class 1 requirement.)
Cytotoxicity	The device is non-cytotoxic	Under the conditions of the study, the device is non-cytotoxic. (Pass)
Irritation	The device is non-irritating	Under the conditions of the study, the device is non-irritating. (Pass)
Sensitization	The device is non-sensitizing	Under the conditions of the study, the device is non-sensitizing. (Pass)

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

The exact location of the testing is not explicitly stated, but the submission is from a company in China. The nature of these tests (e.g., fluid resistance, filtration efficiency) suggests they are laboratory-based performance tests, not clinical studies involving human subjects. Therefore, the data provenance is likely from a certified testing laboratory, and the data is prospective in the sense that the tests were conducted specifically for this submission on newly manufactured devices.

Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability: For each of these tests, 3 batches were tested, with 32 test articles per each batch. This means a total of 96 samples were tested for each performance characteristic.
Biocompatibility (Cytotoxicity, Irritation, Sensitization): The document states "Under the conditions of the study, the device is non-cytotoxic/non-irritating/non-sensitizing," but does not explicitly state the number of samples or animals used for these specific tests within this summary. However, these tests are typically conducted according to ISO 10993 standards, which outline sample size requirements.

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

This document describes non-clinical performance and biocompatibility testing of a medical disposable face mask. It does not involve "ground truth" derived from expert interpretation of medical images or clinical outcomes in the usual sense for AI/medical device submissions.

These tests are evaluated against established international standards and regulatory guidance (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). The "ground truth" here is the pass/fail criteria defined by these standards, which are based on scientific principles and consensus within the relevant industries. The results are objective measurements rather than subjective expert judgments.

Therefore, the concept of "number of experts used to establish the ground truth" and their qualifications is not applicable in this context. The "experts" involved would be the qualified personnel performing the laboratory tests according to the defined protocols.

4. Adjudication Method for the Test Set

As this is objective non-clinical testing against defined standards, an adjudication method like 2+1, 3+1, or none, typically used for resolving discrepancies in expert interpretations (e.g., of medical images), is not applicable. The results are quantitative measurements interpreted against established numerical or qualitative criteria (e.g., "none seen," ">98%", "<6.0mmH2O/cm²"). Any discrepancies would typically be resolved through re-testing or review of the testing methodology by the testing laboratory's quality control system.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a medical disposable face mask, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

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

No, a standalone algorithm performance study was not done. As explained above, this device is a physical medical disposable face mask, not an algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

The ground truth used for these performance and biocompatibility tests is based on established industry standards and regulatory requirements. These standards define the acceptable performance metrics and test methodologies. For example:

Fluid Resistance: Defined by ASTM F1862.
Filtration Efficiency: Defined by ASTM F2299 and ASTM F2101.
Differential Pressure: Defined by EN 14683.
Flammability: Defined by 16 CFR 1610.
Biocompatibility: Defined by ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Sensitization).

These standards provide objective criteria for evaluating the device's technical performance and safety.

8. The Sample Size for the Training Set

Not Applicable. This submission is for a physical medical device (face mask), not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable. As there is no AI algorithm, there is no training set and no ground truth for a training set.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

March 24, 2021

Guangdong Zhong Ling Industrial Group Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, Guangdong 511660 China

Re: K202650

Trade/Device Name: Medical disposable face mask non sterile Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 4, 2021 Received: January 4, 2021

Dear Jinghua Zhou:

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,

For CAPT Elizabeth Claverie, M.S. 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) K202650

Device Name Medical disposable face mask non sterile

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

× Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

K202650

Date of Summary Preparation: March 5, 2021

1. Submitter's Identifications

Submitter's Name: Guangdong Zhong Ling Industrial Group Co., Ltd. Address: Room 101, Building 1, No. 5, Shengfeng Road, Xinhe Wanjiang, Dongguan, Guangdong, China Zip Code: 523045 Contact Person: Ann Ho Contact Title: Chief Financial Officer Contact E-mail Address: ann@dgzhongling.com Telephone: +86-769-22175828 Fax: +86-769-22175838

2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549

3. Name of the Device

Device Classification Name: Mask, Surgical Regulation Description: Surgical apparel Trade Name: Medical disposable face mask non sterile Model: ZL-0001 Regulation Medical Specialty: General & Plastic Surgery Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Device Classification: Class II

4. The Predicate Devices

Surgical Face Mask, Model: Ear Loop K182515 Wuhan Dymex Healthcare Co., Ltd

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5. Device Description

6. Indications for use

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

	Proposed Device	Predicate device	Comparison
510k Number	K202650	K182515
Product Code	FXX	FXX	Same
Proprietary Name	Medical disposableface mask non sterile	Surgical Face Mask
Model	ZL-0001	Ear Loop
Manufacturer	Guangdong ZhongLing IndustrialGroup Co., Ltd.	Wuhan DymexHealthcare Co., Ltd
Indications for Use	The device isintended to be wornto protect both thepatient andhealthcare personnelfrom transfer ofmicroorganisms,body fluids and	The Surgical FaceMasks are intendedto be worn to protectboth the patient andhealthcare personnelfrom transfer ofmicroorganisms,body fluids and	Same
		particulate material.These face masks areintended for use ininfection controlpractices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.	particulate material.These face masks areintended for use ininfection controlpractices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Type of Use		Over-the-counter	Over-the-counter	Same
Structure		Ear Loops, Flat Pleated, 3 layers	Ear Loops, Flat Pleated, 3 layers	Same
	Outerfacinglayer	Spun-bondpolypropylene	Spun-bondpolypropylene	Same
	Middlelayer	Melt blownpolypropylene filter	Melt blownpolypropylene filter	Same
Materials	Innerfacinglayer	Spun-bondpolypropylene	Spun-bondpolypropylene	Same
	Nosepiece	Malleablepolyethylene wire	Malleablepolyethylene wire	Same
	Earloops	Spandex	Spandex	Same
Color		Blue	Yellow	Different1
Dimension		$175mm \times 95mm$	$17.5cm \times 9.5cm (\pm 0.2cm)$	Same
OTC use		Yes	Yes	Same
Sterility		Non-sterile	Non-sterile	Same
Use		Single Use,Disposable	Single Use,Disposable	Same
Fluid ResistancePerformanceASTM F1862		3 batches, synthetic blood penetration of 32 test articles per each batch is none seen at 120mmHg test pressure	32 out of 32 pass at 120mmHg	Same

ParticulateFiltrationEfficiency ASTMF2299	3 batches,average PFE of 32test articles per eachbatch:>99.986%,>99.986%,>99.982%;standard deviation:0.0123,0.0142,0.0389	99.7%	Same
Bacterial FiltrationEfficiency ASTMF2101	3 batches,BFE of 32 testarticles per eachbatch:>99.9%,>99.9%,>99.9%	99.9%	Same
DifferentialPressure (Delta P)EN14683:2019+AC:2019 Annex C, Flowrate 8 L/min	3 batches,Delta P of 32 testarticles per eachbatch:2.7-3.2 mmH2O/cm²,2.7-2.9 mmH2O/cm²,2.6-3.0mmH2O/cm²	4.0mmH2O/cm²	Same
Flammability 16CFR 1610	Class 13 batches, 32 testarticles per eachbatch are ignited, butextinguished	Class 1Non Flammable	Same
Cytotoxicity	Under the conditionsof the study, thedevice isnon-cytotoxic	Under the conditionsof the study, thedevice isnon-cytotoxic	Same
Irritation	Under the conditionsof the study, thedevice is non-irritating	Under the conditionsof the study, thedevice is non-irritating	Same
Sensitization	Under the conditionsof the study, thedevice isnon-sensitizing	Under the conditionsof the study, thedevice isnon-sensitizing	Same
Standard	ASTM F2100-19ISO10993-1	ASTM F2100-19ISO10993-1	Same

Table 1 Comparison to Predicate Device

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Guangdong Zhong Ling Industrial Group Co., Ltd.

ISO10993-5ISO10993-10	ISO10993-5ISO10993-10
---------------------------	---------------------------	--

8. Justification of differences

Note 1: Our device and the predicate device are almost identical in terms of all areas described in the above table (Table 1). The difference in the colors 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 construction materials and color additives.

9. Summary of Non-Clinical Testing:

The proposed devices were tested and conformed to 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.

Item	Proposed device1	Acceptance Criteria	Results
Fluid Resistance ASTM F1862	32 out of 32 pass at 120mmHg	29 out of 32 pass at 120mmHg	3 batches, synthetic blood penetration of 32 test articles per each batch is none seen at 120mmHg test pressure
Particulate Filtration Efficiency ASTM F2299	Level 2≥ 98%	Level 2≥ 98%	3 batches, average PFE of 32 test articles per each batch:>99.986%,>99.986%,>99.982%;standard deviation:0.0123,0.0142,0.0389
Bacterial Filtration Efficiency ASTM F2101	Level 2≥ 98%	Level 2≥ 98%	3 batches, BFE of 32 test articles per each batch:>99.9%,>99.9%,>99.9%

Table 2 Performance testing

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Differential Pressure(Delta P) EN14683:2019+AC:2019Annex C, Flow rate 8L/min	Level 2 <6.0mmH2O/cm²	Level 2 <6.0mmH2O/cm²	3 batches,Delta P of 32 testarticles per eachbatch:2.7-3.2mmH2O/cm²,2.7-2.9mmH2O/cm²,2.6- 3.0mmH2O/cm²
Flammability 16 CFR1610	Class 1	Class 1	Class 13 batches, 32 testarticles per eachbatch are ignited,but extinguished

Note 1: The samples of three various production batches are complied with the requirements of ASTM F2100-19.

Table 3 Biocompatibility testing

Item	Proposed device	Result
Cytotoxicity	Under the conditions of the study, the device is non-cytotoxic	Pass
Irritation	Under the conditions of the study, the device is non-irritating	Pass
Sensitization	Under the conditions of the study, the device is non-sensitizing	Pass

10. Clinical Test Conclusion

No clinical study is included in this submission.

11. 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 K182515 Surgical Face Mask.

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.