The Disposable Medical Surgical Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Device Description

The Disposable Medical Surgical Mask (rectangular) is single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Mask 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 mask is held in place by the elastic ear loops. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask, which is a Class II medical device. The document details the device's characteristics, intended use, and comparative analysis against a predicate device, focusing on non-clinical performance and biocompatibility testing. It is important to note that this document does not describe an AI/ML-driven medical device, and therefore, many of the requested criteria regarding AI model evaluation (e.g., training set, ground truth experts, MRMC studies) are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, as detailed in the non-clinical performance testing section.

Here's the breakdown based on the provided text:

Device Type: Disposable Medical Surgical Mask (Not an AI/ML device)

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

The device performance is evaluated against the ASTM F2100-19 standard for medical face masks, along with other relevant standards for specific tests.

Performance testing Item	Acceptance Criteria	Reported Device Performance	Result
Fluid Resistance ASTM F1862	≥160 mmHg Pass: 29 out of 32 masks at 160 mmHg	29 out of 32 pass at 160 mmHg	Pass
Particulate Filtration Efficiency ASTM F2299	≥ 98%	≥ 98%	Pass
Bacterial Filtration Efficiency ASTM F2101	≥ 98%	≥ 98%	Pass
Differential Pressure (Delta P) MIL-M-36954C	< 6.0mmH2O/cm²	< 6.0mmH2O/cm²	Pass
Flammability 16 CFR 1610	Class 1 Non Flammable	Class 1 Non Flammable	Pass
Barrier protection level	Level 3 (according to ASTM F2100)	Level 3	Pass

Biocompatibility Testing:

Item	Acceptance Criteria (Implied)	Reported Device Performance	Result
Cytotoxicity	Non-cytotoxic	Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.	Pass
Irritation	Non-irritating	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.	Pass
Sensitization	Non-sensitizing	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing.	Pass

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

Sample Size:
- For Fluid Resistance (ASTM F1862): 32 samples were tested, with 29 passing the 160 mmHg threshold.
- For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The specific sample size per test is not explicitly stated but is implied to be sufficient to meet the standards (e.g., "Pass" results).
- For Biocompatibility testing: The sample size for each test (Cytotoxicity, Irritation, Sensitization) is not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that non-clinical tests were conducted. Given the nature of performance and biocompatibility testing for a physical medical product, these are almost certainly prospective laboratory tests following standardized protocols.

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

Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) does not apply here. The "ground truth" for this device is established by the results of standardized laboratory tests conducted according to established protocols (e.g., ASTM, ISO standards).

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

Not Applicable. As this is a performance evaluation of a physical device against predefined quantitative standards, an adjudication method for human interpretation is not relevant. The results are objective measurements from laboratory equipment.

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 device is a surgical mask, not an AI-driven diagnostic or assistive tool. Therefore, MRMC studies are not 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 a software algorithm.

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

Standardized Test Results / Quantitative Measurements: The "ground truth" is based on the objective outcomes of laboratory tests performed according to recognized industry standards (e.g., ASTM F2101 for Bacterial Filtration Efficiency, ASTM F1862 for Fluid Resistance). These standards define the methodology and the acceptable performance thresholds.

8. The sample size for the training set:

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

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

Not Applicable. As there is no AI/ML model or training set, the concept of establishing ground truth for a training set does not apply.

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 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.

January 12, 2021

Tianjin Saiyuan Technology CO., LTD % Wang Yanhong RA Engineer Andon Health Co.. Ltd No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China

Re: K201625

Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 23, 2020 Received: October 26, 2020

Dear Wang Yanhong:

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 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, MS 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) K201625

Device Name

Disposable Medical Surgical Mask (rectangular)

Indications for Use (Describe)

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

	Dissemination Use (Ref 21 CFR 601.2 Subpart D)
	Own-Use; Compassionate Use (21 CFR 601.2 Subpart E)

_ | 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 summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter's information

Name: TIANJIN SAIYUAN TECHNOLOGY CO.,LTD Address: 18 DongJiu Street, Zhongxin Road, Pilot Free Trade Zone (Airport Economic Area) , Tianjin, CN 300308

Phone number: 86-22-60406905 86-22-60406912 Fax number: Contact: Hong Cai Date of Preparation: 1/11/2021

2.0 Device information

Trade name: Disposable Medical Surgical Mask (rectangular) Common name: surgical mask Regulation Name: Surgical Apparel

3.0 Classification

Production code: FXX Regulation number: 21 CFR §878.4040 Classification: II Panel: General Hospital

4.0 Predicate device information

Manufacturer: WUHAN DYMEX HEALTHCARE CO., LTD Device: SURGICAL FACE MASK 510(k) number: K182515

5.0 Intended use

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The Disposable Medical Surqical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

6.0 Device description

This device is not made from Natural Rubber Latex.

Item	Subject Device	Predicate Device (K182515)	Comparison
Manufacturer	TIANJIN SAIYUANTECHNOLOGY CO.,LTD	WUHAN DYMEXHEALTHCARECO., LTD	Different note 1
510K number	K201625	K182515	Different note 2
Product name	Surgical mask	Surgical face mask	Different note 3
classification	Class II device, FXX (21 CFR878.4040)	Class II device, FXX (21 CFR878.4040)	Same
Indications forUse	The Disposable Medical SurgicalMask is intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,blood, body fluids and particulatematerial. This surgical mask isintended for use in infectioncontrol practices to reduce	The Surgical Face Masks areintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices to	Same

7.0 Summary comparing technological characteristics with predicate device

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	potential exposure to blood andbody fluids. This is a single use,disposable device, providednon-sterile.	reduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile.
Model	rectangular	Ear loops, flat pleated, 3 layers	Different note 4
materials	Outer facing layer:Spun-bond polypropylene	Outer facing layer:Spun-bond polypropylene	Same
	Middle facing layer:Melt blown polypropylene filter	Middle facing layer:Melt blown polypropylene filter	Same
	Inner facing layer:Spun-bond polypropylene	Inner facing layer:Spun-bond polypropylene	Same
	Nose piece:Malleable polyethylene wire	Nose piece:Malleable polyethylene wire	Same
	Ear loops:Spandex and nylon	Ear loops:Spandex	Different note 5

Color	Outside: BlueInside: white	Yellow	Different note 6
Dimension(Width)	9.5cm±1cm	9.5cm±1cm	Same
Dimension(Length)	17.0cm±1cm	17.5cm±1cm	Different note 7
Mask style	flat-folded	flat-folded	Same
OTC use	Yes	Yes	Same
Sterility	Non-sterile	Non-sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100Level	Level 3	Level 2	Different note 8

Note 1-4: the manufacturer is different, so the device name, 510K number and model number is different. The performance test conform that the new device is the same safe and effective as the predicate device.

Note 5: There is nylon material in the ear loop of the proposed device, which is different from the predicate device, however, Nylon is a popular material used in cloths, and the biocompatibility test also demonstrated the material is as safe as the predicate device.

Note 6: The color of the outer facing layer is different from the predicate device, but the biocompatibility test also demonstrated the material is as safe as the predicate device.

Note 7: Dimension of width is the same as the predicate device, while dimension of length of is different, the performance test proves the device is the same safe and effective as the predicate device.

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Note 8: The new device is level 3 according to ASTM F2100 standard, the performance test conform that, the difference does not raise any new performance questions.

8.0 Discussion of non-clinical test performed

Non-clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The test results demonstrate that the proposed device conforms to the recognized standards ASTM F2100-19, ASTM F1862, ASTM F2101, and ISO 10993 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.

ASTM F2100Level	Level 3	Level 2	Different note 8
---------------------	---------	---------	------------------

Performance testing
Item	Proposed device	Acceptance criteria	Result
Fluid ResistancePerformance ASTMF1862	≥160 mmHg	29 out of 32 pass at 160mmHg	Pass
Particulate FiltrationEfficiency ASTM F2299	≥ 98%	≥ 98%	Pass
Bacterial FiltrationEfficiency ASTM F2101	≥ 98%	≥ 98%	Pass
Differential Pressure(Delta P) MIL-M-36954C	< 6.0mmH2O/cm²	< 6.0mmH2O/cm²	Pass
Flammability 16 CFR1610	Class 1Non Flammable	Class 1	Pass
Barrier protection level	Level 3	Level 3	Pass

Performance testing

Biocompatibility testing

Item	Proposed device	Result
Cytotoxicity	Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.	Pass
Irritation	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.	Pass
Sensitization	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing.	Pass

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9.0 Clinical Test Conclusion

No clinical study is included in this submission.

10.0 Comparison to the predicate device and the conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K201625, Disposable Medical Surgical Mask (rectangular), is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.

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.