The Medical surgical mask 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, provided non-sterile.

Device Description

The Medical surgical mask is Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical surgical mask is manufactured with three layers. The outer layer is made of polypropylene (PP) non-woven fabric with blue color. The middle layer is filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene (PP) non-woven fabric with white color. The Medical surgical mask is single use, disposable device, provided non-sterile.

AI/ML Overview

This document is a 510(k) premarket notification for a Medical Surgical Mask (K210380), aiming to demonstrate substantial equivalence to a predicate device (K160269).

The acceptance criteria for this device are based on performance standards outlined in ASTM F2100-19 for medical face masks. The study proving the device meets these criteria is a non-clinical performance test.

Here's a breakdown of the requested information based on the provided document:

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

Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Results - 3 Lots)
ASTM F1862M-17	Fluid Resistance Performance	29 out of 32 pass at 160mmHg	Pass
ASTM F2299	Particulate Filtration Efficiency	≥98%	Pass
ASTM F2101-19	Bacterial Filtration Efficiency	≥98%	Pass
EN 14683:2019 Annex C	Differential Pressure	< 6.0mmH2O/cm²	Pass
16 CFR 1610	Flammability	Class I non flammable	Pass

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

Sample Size for Test Set:
- For Fluid Resistance Performance (ASTM F1862M-17): The acceptance criteria state "29 out of 32 pass," indicating a sample size of 32 units tested.
- For Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101-19), Differential Pressure (EN 14683:2019 Annex C), and Flammability (16 CFR 1610): The exact sample size for these tests is not explicitly stated in the provided text. However, "Results (3 Lots)" implies that samples from three different production lots were tested, and all tests passed.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given that this is a 510(k) submission from "Shantou T&K Medical Equipment Factory Co.,Ltd" in China, it's highly probable the testing was conducted in China, and it would be prospective as it's for a new device submission.

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

This information is not applicable to this type of testing. The tests conducted are standardized physical and performance tests for medical masks, not subjective evaluations requiring expert consensus on ground truth (like image interpretation). The "ground truth" is established by the specifications of the ASTM and EN standards themselves.

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

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads). For these non-clinical performance tests, there is no adjudication method in the sense of reconciling different expert opinions. The pass/fail is determined by objective measurements compared against predefined criteria.

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 MRMC comparative effectiveness study was done. This device is a medical surgical mask, not an AI-powered diagnostic tool requiring human-in-the-loop assessment. The document explicitly states: "No clinical study is included in this submission."

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

No standalone algorithm performance was done. This is not an AI/algorithm-based device.

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

The "ground truth" for these non-clinical tests is based on standardized test methodologies and pre-defined quantitative performance thresholds set by organizations like ASTM and EN. For example:
- Fluid Resistance: Number of passed specimens at a specific pressure.
- Filtration Efficiency: Measured percentage of particles/bacteria filtered.
- Differential Pressure: Measured pressure difference across the mask material.
- Flammability: Classification based on burn rate.

8. The sample size for the training set

Not applicable. This device is a physical medical product (mask), not an AI model that requires a training set.

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

Not applicable. As stated above, there is no training set for this device.

Summary

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July 8. 2021

Shantou T&K Medical Equipment Factory Co.,Ltd % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai, 200071 China

Re: K210380

Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 26, 2021 Received: May 28, 2021

Dear Stuart Situ:

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.

Clarence W. Murray, III, 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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Indications for Use

510(k) Number (if known) K210380

Device Name Medical surgical mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 K210380

I. Submitter

Shantou T&K Medical Equipment Factory Co.,Ltd No.8 Workshop, Wanji South Second Street Shantou, Guangdong CN515065

Establishment Registration Number: 3016710550

Contact person: Wan Li Position: Manager Tel.: +86 15992258456 E-mail: triangel.wan@163.com

Preparation date: July.8, 2021

II. Proposed Device

Trade Name of Device:	Medical surgical mask
Common name:	Surgical Mask
Regulation Number:	21 CFR 878.4040
Regulatory Class:	Class II
Product code:	FXX
Review Panel:	General Hospital

III. Predicate Devices

510(k) Number:	K160269
Trade name:	Surgical Face masks (Ear loops and Tie-on)
Common name:	Surgical Mask
Classification:	Class II
Product Code:	FXX
Manufacturer	San-M Package Co., Ltd.

IV. Device Description

The Medical surgical mask is Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose.

The Medical surgical mask is manufactured with three layers. The outer layer is made

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of polypropylene (PP) non-woven fabric with blue color. The middle layer is filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene (PP) non-woven fabric with white color.

The Medical surgical mask is single use, disposable device, provided non-sterile.

V. Indication for Use

VI. Comparison of Technological Characteristics with the Predicate Devices

Item	Proposed Device (K210380)	Predicate Device (K160269)	Comparison
Trade Name	Medical surgical mask	Surgical Face masks (Ear loops and Tie-on)	Different
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	Class II	Class II	Same
Mask Style	Flat-pleated, ear loops, 3 layers	Flat-pleated, ear loops or tie-on, 4 layers	Different
Indication for Use	The Medical surgical 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	The Surgical face masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluid, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single-use, disposable devices provided non-sterile.	Similar

Table 10-1 General Comparison

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single use, disposable
device, provided non-sterile.

Material	Innerlayer		Polypropylene	Different
	Middlelayer	Polypropylene melt-blownnon-woven fabric	1. Polypropylene spun-bond2. Polypropylene melt blown	Similar
	Outerlayer	Polypropylenenonwoven	Polypropylene	Similar
	Ear loops	Ear loops: SpandexTie bands:Polypropylenenonwoven	Ear loops: Polyester, polyurethane;Side tapes: Polyesterspun-bond (ear loops maskonly)Ties tapes: Polypropylenespun-bond or polyesterspun-bond	Different
	Nosepiece	PP、PE, galvanized	Polyethylene coatedsteel wire	Different
Color		Blue	Blue ,white	Different
Dimension		17.5cmx9.5cm	17.5cmx9.0cm18.0cmx9.0cm	Similar
OTC Use		Yes	Yes	Same
Sterile		Non-sterile	Non-sterile	Same
For single Use		Yes	Yes	Same
ASTM F2100Level		Level 3	Level 1: Pass at 80mmHgLevel 2: Pass at 120mmHgLevel 3: Pass at 160mmHg	Similar

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Biocompatibility	Confirm to therequirements ofISO 10993 seriesstandards	Confirm to the requirements ofISO 10993 series standards	Same
------------------	--------------------------------------------------------------------	--------------------------------------------------------------	------

V. Non-Clinical Testing

Non-clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the standards of ASTM F2100-19:

Methodology	Purpose	Acceptance Criteria	Results (3 Lots)
ASTM F1862M-17	Fluid ResistancePerformance	29 out of 32 pass at160mmHg	Pass
ASTM F2299	Particulate FiltrationEfficiency	≥98%	Pass
ASTM F2101-19	Bacterial FiltrationEfficiency	≥98%	Pass
EN 14683:2019Annex C	Differential Pressure	< 6.0mmH2O/cm²	Pass
16 CFR 1610	Flammability	Class I non flammable	Pass

VI. Clinical Testing

No clinical study is included in this submission.

VII.Conclusion

The conclusion drawn from the non-clinical performance testing data demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate device, Surgical Face masks (K160269).

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.