The Disposable 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. The Disposable Surgical Masks are single use, disposable device, provided non-sterile.

Device Description

Disposable Surgical Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (High-density Polyethylene) to provide a firm fit over the nose. There are four models for Disposable Surgical Mask with different colors and sizes. All six models are Ear Loop type in blue or white colors and two sizes including 145mm×90mm and 175×95mm.

AI/ML Overview

The provided document is a 510(k) summary for a Disposable Surgical Mask (K210042). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria in the context of an AI/ML medical device. The document details performance testing for physical and material properties of the surgical masks.

Therefore, most of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of device and submission.

However, I can extract the relevant acceptance criteria and performance data for the Disposable Surgical Mask as presented in the document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Performance):

This table is directly from the "IX. PERFORMANCE DATA" section of the document. The acceptance criteria and results refer to the physical and barrier performance of the surgical mask material.

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Bacterial Filtration Efficiency	To determine the bacterial filtration efficiency (BFE)	Level 2 ≥ 98%	32/32 Passed at ≥99.9%
Particulate Filtration Efficiency	To determine the particle filtration efficiency (PFE)	Level 2 ≥ 98%	32/32 Pass at ≥99.5%
Differential Pressure (delta-P)	To measure breathability/resistance to airflow	Level 2 < 6.0 mmH2O/cm²	32/32 Pass at <4.3 mmH2O/cm²
Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result	To evaluate effectiveness against exposure to blood and other body fluids	Level 2: No penetration at 120 mmHg	32/32 Passed at 120mmHg
Flammability	To measure the flammability of masks	Level 2: Class 1	32/32 Passed Class 1 requirement
Cytotoxicity (ISO10993-5)	Biological evaluation	Subject device extract determined to be non-cytotoxic	Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.
Irritation (ISO10993-10)	Biological evaluation	Subject device non-polar and polar extracts determined to be non-irritating	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.
Sensitization (ISO10993-10)	Biological evaluation	Subject device non-polar and polar extracts determined to be non-sensitizing	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing.

Study that Proves the Device Meets Acceptance Criteria (as described for this non-AI/ML device):

The document states: "Non-clinical tests were conducted to verify that the proposed device met all design specifications found in the test methodology and standard using 3 nonconsecutive lots." The "Test Methodology" column in the table above lists the specific ASTM, EN, MIL-M, and ISO standards used for each test. The "Results" column confirms that the device passed all specified acceptance criteria for these physical and biological tests.

Regarding AI/ML specific questions (which are NOT applicable to this document):

2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "sample size" is the number of mask samples tested (e.g., "32/32 Passed"). Data provenance would be from laboratory testing results based on specific mask lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-AI/ML medical devices like surgical masks is established via objective physical and biological tests against established industry standards.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, the "ground truth" is defined by compliance with the specified performance standards (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE, 16 CFR Part 1610 for Flammability, ISO 10993-X for biocompatibility).
8. The sample size for the training set: Not applicable. No AI/ML model for training.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a traditional medical device (surgical mask) and describes its physical and biological performance testing, not the performance of an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 17, 2021

Suzhou Letian Protective Products Co., Ltd. % Ryan Li RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China

Re: K210042

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 22, 2021 Received: September 29, 2021

Dear Ryan Li:

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 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210042

Device Name

Disposable Surgical Mask, Blue(Model; LT-0175A, LT-0145A) Disposable Surgical Mask, White (Model: LT-0175B, LT-0145B)

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-K210042

I. SUBMITTER:

Suzhou Letian Protective Products Co., Ltd. No. 12 Zhenfeng Road, Nanfeng Town, Suzhou City, Jiangsu Province, 215600, China

Contact Person: Huang Qizhi Title: Integrated Manager Tel: +86 13701567601

Email: huangqizhi@szltfhypwwgc.onexmail.com

Submission Correspondent: Ryan Li Email: ryan.li(@mind-link.net Tel:+86 13701581791

Summary prepared: September 17th, 2021

II. DEVICE

Name of Device: Disposable Surgical Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II

Product Code: FXX

III. PREDICATE DEVICE

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Primary predicate device: Surgical Face Masks (K182514)

IV. REFERENCE DEVICE

Reference device: Face Mask (K210007)

V. DEVICE DESCRIPTION

There are four models for Disposable Surgical Mask with different colors and sizes. All six models are Ear Loop type in blue or white colors and two sizes including 145mm×90mm and 175×95mm.

VI. AVAILABLE MODELS

REF No.	Product	Model Description		Mask Color
	Size	Mask	Ear Loop	Blue	White
LT-0145A	145×90mm	X	X	X
LT-0175A	175×95mm	X	X	X
LT-0145B	145×90mm	X	X		X
LT-0175B	175×95mm	X	X		X

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VII. INDICATIONS FOR USE

The Disposable 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. The Disposable Surgical Face Masks are single use, disposable device, provided non-sterile.

VIII. TECHNOLOGICAL CHARACTERISTICS COMPARISON

The Disposable Surgical Masks are compared with the predicate device (Surgical Face Masks (K182514)):

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Device	Subject Device	Primary Predicate Device
	Disposable Surgical Mask(K210042)	Surgical Face Mask(K182514 )	Comparison
Intended Use	The Disposable Surgical Face Masksare intended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms, bodyfluids and particulate material.These face masks are intended for usein infection control practices to reducethe potential exposure to blood andbody fluids. The Disposable SurgicalFace Masks are single use, disposabledevice, provided non-sterile.	The surgical face masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms,body fluids, andparticulate material.These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile.	Same
ClassificationProduct Code	FXX	FXX	Same
Ear LoopModel	Ear Loops	Ear Loops	Same
Outer Facing Layer	Spun-bondpolypropylenenon-woven fabric	Spun-bond polypropylene	Similar Note 1
Middle Layer	Melt-blown polypropylene	Melt blown polypropylenefilter	SimilarNote 1
Inner Facing Layer	Spun-bondpolypropylenenon-woven fabric	Spun-bond polypropylene	Similar Note 1
Nose Piece	High-density polyethylene	Malleable aluminum wire	SimilarNote 1
Ear Loops	80% Spandex20% Polyester	Polyester	Similar Note 1
Color	Blue, white	White	Different Note 1
Style	Flat - Pleated	Flat - Pleated	Same
MultipleLayers	3 Layers	3 Layers	Same
Single Use	Single use	Single use	Same
Sterile	Non-sterile	Non-sterile	Same
Length $\times$ Width	$145 \times 95$ mm ( $\pm$ 10mm)$175 \times 95$ mm ( $\pm$ 10mm)	Length: 95 $\pm$ 10mmWidth:175 $\pm$ 10mm	Different Note 2
Fluid ResistanceASTM F1862	32 out of 32 pass at120mmHg	32 out of 32 pass at120mmHg	Same
Particulate FiltrationEfficiency (PFE) ASTMF2299	Pass at $\ge$ 99.5%	Pass at 99.88%	Similar
Bacterial FiltrationEfficiency (BFE) ASTMF2101	Pass at $\ge$ 99.9%	Pass at 99.6%	Similar
Differential Pressure(Delta P)MIL-M-36954C	Pass at $<4.3$ mmH2O/cm2	Pass at 3.0 mmH2O/cm2	Similar
Flammability 16 CFRPART 1610	Class 1 Non-Flammable	Class 1 Non-Flammable	Same
Cytotoxicity	Under the conditions of the study, thesubject device extract was determined tobe non-cytotoxic.	Under the conditions of the study, thesubject device extract wasdetermined to be non-cytotoxic.	Same
Irritation	Under the conditions of the study, thesubject device non-polar and polarextracts were determined to be non-irritating.	Under the conditions of the study, thesubject device non-polar and polarextracts were determined to be non-irritating.	Same
Sensitization
	Under the conditions of the study, thesubject device non-polar and polarextracts were determined to be non-sensitizing.	Under the conditions of the study, thesubject device non-polar and polarextracts were determined to be non-sensitizing.	Same

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Comparison in Detail(s): Note 1:

Although the material including outer facing layer, middle layer, inner facing layer, nose piece and ear loops, as well as the color of the subject device and the color is different from the predicate device.

Note 2:

Although LT-O145A and LT-O145B models of the subject device are smaller than the predicate device, these models match the dimension with reference device (K210007, Model: Type A), the barrier protection performance of the subject device is same with the barrier protection performance of predicate device and the reference device, which is the Level 2 barrier protection.

IX. PERFORMANCE DATA

Non-Clinical Performance Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications found in the test methodology and standard using 3 nonconsecutive lots. The test results demonstrated that the Disposable Surgical Masks complies with the following standards:

ASTM F2100-19 Standard Specification for Performance of Materials Used ● in Medical Face Masks
ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to . Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
EN 14683:2019+AC2019(E) Annex C ●

ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

. ASTM F2101 Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Page 7 of 9

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Aerosol of Staphylococcus aureus

MIL-M- 36954C Military Specification, Mask, Surgical, Disposable .
16 CFR Part 1610 Standard for the Flammability of Clothing ●
ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
. ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization

Test Methodology	Purpose	Acceptance Criteria	Results
Bacterial FiltrationEffciency	The test was performed inaccordance with ASTM F2101:2019 Standard Test Method forEvaluating the BacterialFiltration Efficiency (BFE) ofMedical FaceMask Materials, Using aBiological Aerosol ofStaphylococcus aureus todetermine the bacterialfiltration efficiency(BFE) of	Level 2≥98%	32/32 Passed at ≥99.9%
Particulate FiltrationEfficiency	The test was performed inaccordance with ASTM F2299Standard Test Method forDetermining the InitialEfficiency of Material Usedin medical Face Masks toPenetration by Particulatesusing Latex Spheres todetermine the particle filtrationefficiency (PFE) of	Level 2≥98%	32/32 Pass at ≥99.5%
Differential Pressure	The test was performed in	Level 2<6.0mmH2O/cm²	32/32 Pass at <4.3

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(delta-P)	accordance with EN14683:2019+AC;2019(E)Annex C		mmH2O/cm²
Resistance topenetration bysynthetic blood,minimum pressure inmm Hg for passresult	The test was performed inaccordance with ASTMF1862/F1862M Standard TestMethod for Resistance ofMedical Face Masks toPenetration by Synthetic Blood(HorizontalProjection of FixedVolume at a Known Velocity)to evaluate the effectiveness ofthe test sample from possibleexposure to blood and otherbody fluids.	Level2: No penetration at120 mmHg	32/32 Passed at120mmHg
Flammability	The test was performed inaccordance with 16 CFR Part1610 Standard for theFlammability of Clothing tomeasure the flammability ofmasks	Level2: Class 1	32/32 Passed Class 1requirement

Clinical Test Conclusion

No clinical study is included in this submission.

X. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device Surgical Face Masks (K182514).

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.