The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Device Description

The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.

AI/ML Overview

The document describes the testing and acceptance criteria for a "Disposable Surgical Face Mask" (K212649). This is a medical device, not an AI/ML device, therefore, many of the requested categories such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set" are not applicable.

Here's the information extracted and organized as requested, with "N/A" for sections not relevant to a non-AI medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

No	Item	Test Method/Standard	Type	Acceptance Criteria	Reported Performance for Ear Loop Type	Reported Performance for Tie-on Type
1	Particulates Filtration Efficiency	ASTM F2299/F2299M-03(2017)	Ear loop	≥98%	Lot 1: 98.81%Lot 2: 98.78%Lot 3: 98.8%	N/A (listed separately below)
			Tie-on	≥98%	N/A (listed above)	Lot 1: 98.82%Lot 2: 98.78%Lot 3: 98.79%
2	Bacterial Filtration Efficiency	ASTM F2101-19	Ear loop	≥98%	Lot 1: 99.9%Lot 2: 99.91%Lot 3: 99.91%	N/A (listed separately below)
			Tie-on	≥98%	N/A (listed above)	Lot 1: 99.91%Lot 2: 99.9%Lot 3: 99.91%
3	Fluid Resistance	ASTM F1862/F1826M-17	Ear loop	120 mmHg	Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg	N/A (listed separately below)
			Tie-on	120 mmHg	N/A (listed above)	Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg
4	Differential Pressure	EN 14683:2019	Ear loop	△P<6.0 mm H2O/cm2	Lot 1: 3.59Lot 2: 3.59Lot 3: 3.59	N/A (listed separately below)
			Tie-on	△P<6.0 mm H2O/cm2	N/A (listed above)	Lot 1: 3.61Lot 2: 3.59Lot 3: 3.61
5	Flammability	ASTM F2100-19	Ear loop	Class 1	Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1	N/A (listed separately below)
			Tie-on	Class 1	N/A (listed above)	Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1

Biocompatibility Tests:

No	Item	Test Method/Standard	Acceptance Criteria	Results
1	Cytotoxicity	ISO 10993-5	Non-cytotoxic	Pass (No potential toxicity)
2	Irritation	ISO 10993-10	Non-irritating	Pass (No Irritation)
3	Skin Sensitization	ISO 10993-10	Non-sensitizing	Pass (No Sensitization)

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

For all performance tests (Particulates Filtration Efficiency, Bacterial Filtration Efficiency, Fluid Resistance, Differential Pressure, Flammability):

Sample Size: 3 non-consecutive lots were tested for each type (Ear loop and Tie-on). For each lot, a sample size of 125 was used.
Data Provenance: Not explicitly stated as country of origin, but the submission is from Lyncmed Medical Technology (Beijing) Co., Ltd. in China, implying testing was likely conducted in or for the company's region. The tests are described as "Non-Clinical Test Conclusion," meaning they were laboratory tests, not clinical studies involving human patients. The report does not specify if the provenance is retrospective or prospective for the samples used for testing.

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

N/A. This is a physical medical device, and the acceptance criteria are based on standardized performance tests (e.g., ASTM, EN, ISO standards), not on human expert interpretation of data or images.

4. Adjudication Method for the Test Set

N/A. As above, the acceptance criteria are based on objective physical and material performance standards.

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

N/A. This is a physical medical device, not an AI/ML device.

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

N/A. This is a physical medical device. No algorithm is involved.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is defined by the objective measurement criteria and threshold values specified in various international and national standards (e.g., ASTM F2299, ASTM F2101, ASTM F1862, EN 14683, ASTM F2100 for performance and ISO 10993 for biocompatibility). These standards set the quantitative benchmarks that the device must meet.

8. The Sample Size for the Training Set

N/A. This is a physical medical device, not an AI/ML device. There is no "training set."

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

N/A. This is a physical medical device. There is no "training set" and therefore no ground truth establishment for it.

Summary

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

October 25, 2022

Lyncmed Medical Technology (Beijing) Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 China

Re: K212649

Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 26, 2022 Received: September 30, 2022

Dear Diana Hong:

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 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,

Bifeng Qian, M.D., Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212649

Device Name Disposable 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

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

The assigned 510(k) Number: K212649

1. Date of Preparation: 10/24/2022
1. Sponsor Identification

Lyncmed Medical Technology (Beijing) Co., Ltd.

Room 1601, Building No.2, Zhubang 2000 Business Building, Balizhuang Xili 99, Chaoyang District, 100022 Beijing, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: 3013678400

Contact Person: Joyce Jiang Position: RA Manager Tel: +86-10-8646 8058 Email: joycejiang@lyncmed.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Disposable Surgical Face Mask Common Name: Surgical mask

Regulatory Information Classification Name: Mask, Surgical Classification: II Product Code: FXX

Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Indication for use:

Device Description:

న్. Identification of Predicate Device
510(k) Number: K202029 Product Name: Medical Surgical Mask
1. Comparison of Technology with Predicate Device

ITEM	Proposed Device K212649	Predicate Device K202029	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	The disposable surgical face mask is intended for single use by operating room personnel and	The medical surgical mask is intended for single use by operating room personnel and	Same

	other general healthcare workersto protect both patients andhealthcare workers against transferof microorganisms, blood andbody fluids, and particulatematerials.	other general healthcare workersto protect both patients andhealthcare workers againsttransfer of microorganisms,blood and body fluids, andparticulate materials.
Mask style	Flat pleated	Flat pleated	Same
Mask color	Blue	Blue	Same
Design feature	Ear loop or tie-on	Ear loop or tie-on	Same
Dimension	175mm×95 mm165mm×85mm	175mm×95mm145mm×90mm120mm×70mm	Difference
Level	Level II	Level II	Same
Fluid Resistance	Pass at 120mmHg	Pass at 120mmHg	Same
Particulate efficiency level	Average 99.9%	Average 98.87%	Difference
Bacterial filtration level	Average 99.9%	Average 99.46%	Difference
Differential pressure	Average 3.63mmH2O/cm2	Average 3.72mmH2O/cm2	Difference
Flammability	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Patient Contacting Material
Ear loops	Polyurethane and spandex	Nylon and polyurethane (PU)	Difference
Tie strings	PP non-woven cloth	Nylon
Nose clip	Iron, zinc and polyethylene (PE)crosslinking material	Iron and polyethylene
Mask body	25g/m2 Polypropylene (PP) non-woven cloth	25g/m2 Polypropylene (PP) non-woven cloth
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Same
Sensitization	No Sensitization	No Sensitization	Same
Irritation	No Irritation	No Irritation	Same
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6
Ethylene oxide residuals	EO<4mg/device, ECH<9mg/device		EO<4mg/device, ECH<9mg/device

Table 1 Comparison of Surgical Mask

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Difference- Dimension

The dimension for the proposed device is different from predicate device. This difference does not affect intended use and will not raise any safety issues. In addition, the mask dimension of the proposed device is within the size range of the predicate device.

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Difference -Particulate efficiency level

The test result for particulate efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Difference-Bacterial filtration level

The test result for bacteria efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Difference-Differential pressure

The test result for different pressure for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Difference-Patient Contacting Material

The patient contact material for the proposed device is different from predicate device. However, biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
EN 14683:2019 Medical face masks-Requirements and test methods
CPSC CS-191-53 Flammability Test Method (16 CFR 1610)
ISO 10993-7:2008 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals

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No	Item	Test Method/Standard	Type	AcceptanceCriteria	Results
1	ParticulatesFiltrationEfficiency	ASTM F2299/F2299M-03(2017)	Ear loop	≥98%	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: 98.81%Lot 2: 98.78%Lot 3: 98.8%
			Tie-on	≥98%	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: 98.82%Lot 2: 98.78%Lot 3: 98.79%
2	Bacterialfiltrationefficiency	ASTM F2101-19	Ear loop	≥98%	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: 99.9%Lot 2: 99.91%Lot 3: 99.91%
			Tie-on	≥98%	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: 99.91%Lot 2: 99.9%Lot 3: 99.91%
3	FluidResistance	ASTM F1862/F1826M-17	Ear loop	120 mmHg	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg
			Tie-on	120 mmHg	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg
4	DifferentialPressure	EN 14683:2019	Ear loop	△P<6.0 mmH2O/cm2	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: 3.59Lot 2: 3.59Lot 3: 3.59
			Tie-on	△P<6.0 mmH2O/cm2	Passed3 non-consecutive lots tested, using asample size of 125/lot

Table 2 Summary of the Non-clinical Testing
---------------------------------------------	--

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					sample size of 125/lotLot 1: 3.61Lot 2: 3.59Lot 3: 3.61
5	Flammability	ASTM F2100-19	Ear loop	Class 1	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: Class 1Lot 2: Class 1Lot 3: Class 1
			Tie-on	Class 1	Passed3 non-consecutive lots tested, using asample size of 125/lotLot 1: Class 1Lot 2: Class 1Lot 3: Class 1

Biocompatibility

In accordance with ISO10993-1 the syringe and needle are classified as: contacting intact skin, Limited Contact (< 24hrs). The following testing was conducted:

Cytotoxicity (ISO 10993-5)
Irritation (ISO 10993-10)
Skin Sensitization (ISO 10993-10)

No	Item	Test Method/Standard	AcceptanceCriteria	Results
1	Cytotoxicity	ISO 10993-5	Non-cytotoxic	PassUnder the condition of this study,the device has no potential toxicity.
2	Irritation	ISO 10993-10	Non-irritating	PassUnder the condition of this study,the device has no Irritation.
3	Skin Sensitization	ISO 10993-10	Non-sensitizing	PassUnder the condition of this study,the device has no Sensitization.

Table 3 Summary of the Biocompatibility testing

The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10 · EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 2 year shelf-life.

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8. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Conclusion 9.
The conclusion drawn from the nonclinical tests demonstrates that the subject device in the 510(k) submission, the Disposable Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202029.

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.