The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood 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 Fluid Resistant Procedure Masks are 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 Fluid Resistant Procedure Masks are manufactured with three layers. The outer layer is made of spun-bond polypropylene non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene non-woven fabric. The inner layer which contacts with face is made of spun-bond polypropylene non-woven fabric. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a Disposable Surgical Mask/Fluid Resistant Procedure Mask. This document describes the device's technical specifications and non-clinical performance testing against established standards to demonstrate substantial equivalence to a predicate device. It does not involve AI or algorithms, so many of the requested categories (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "Ground truth for training set") are not applicable.

Here's the summary of the acceptance criteria and study information found in the document:

1. Table of acceptance criteria and reported device performance:

Methodology/Standard	Purpose	Acceptance Criteria	Reported Device Performance
ASTM F1862M-17	Fluid Resistance Performance	29 out of 32 pass at 160mmHg	Pass (95/96)
ASTM F2299	Particulate Filtration Efficiency	≥98%	Pass (96/96) Average 99.9% at 0.1µm
ASTM F2101-19	Bacterial Filtration Efficiency	≥98%	Pass (96/96) Average 99.9%
EN 14683:2019 Annex C	Differential Pressure	<6mmH2O/cm²	Pass (96/96) Average 3.52 mmH2O/cm²
16 CFR 1610	Flammability	Class I Non Flammable	Pass (96/96) Meet Class I
ISO 10993-5:2009	Cytotoxicity	Non-cytotoxic	Non-cytotoxic
ISO 10993-10:2010	Skin Irritation	Non-irritating	Non-irritating
ISO 10993-10:2010	Skin Sensitization	Non-sensitizing	Non-sensitizing

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

Sample size: For each performance testing (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), 32 samples from each of 3 non-consecutive lots were used, totaling 96 samples per test. Biocompatibility tests (Cytotoxicity, Skin Irritation, Skin Sensitization) also indicated testing was performed, with results confirming acceptance criteria, but specific sample sizes for these individual biocompatibility tests are not explicitly stated beyond "under the conditions of the study."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It describes non-clinical performance tests conducted by the submitter to verify the device met design specifications.

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

Not Applicable. This document describes non-clinical performance testing of a physical medical device (surgical masks) against established industry standards for material properties and performance. It does not involve expert interpretation or subjective evaluation typically associated with establishing ground truth for diagnostic or AI devices.

4. Adjudication method for the test set:

Not Applicable. As per point 3, this is non-clinical device performance testing against objective standards, not a clinical study requiring adjudication of findings.

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 is not an AI-powered device or a study involving human readers.

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

Not Applicable. This is not an algorithm or AI device. The testing describes the standalone performance of the physical surgical mask itself against specified metrics.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on established objective industry standards and testing methodologies (e.g., ASTM F1862M-17 for Fluid Resistance, ASTM F2299 for Particulate Filtration Efficiency, ISO 10993 for Biocompatibility). The device's performance is measured against the predefined acceptance criteria of these standards.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. This is not an AI/machine learning device.

Summary

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February 25, 2021

LHM Medical Technology (Hong Kong) Limited Frank Cheng Senior Manager of Quality Control Unit No. 2. 3/F., Block A. Ko Fai Industrial Building, 7 Ko Fai Road,Yau Tong HongKong, 999077 China

Re: K202240

Trade/Device Name: Disposable Surgical Mask/Fluid Resistant Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 6, 2021 Received: February 9, 2021

Dear Frank Cheng:

We have reviewed vour 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,

Ryan Ortega -S

Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202240

Device Name Disposable Surgical Mask Fluid Resistant Procedure 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: K202240

l. Submitter

LHM Medical Technology (Hong Kong) Limited Unit No. 2, 3/F., Block A, Ko Fai Industrial Building, No. 7 Ko Fai Road, Yau Tong, Kowloon, Hong Kong

Establishment Registration Number: 3016866341

Contact person: Frank Cheng Position: Senior Manager of Quality Control Tel.: +852-27558748- Ext1169 E-mail: frank.cheng@liphing.com

Preparation date: Feb.15, 2021

II. Proposed Device

Trade Name of Device:	Disposable Surgical Mask / Fluid Resistant Procedure 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

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The outer layer is made of spun-bond polypropylene non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene non-woven fabric. The inner layer which contacts with face is made of spun-bond polypropylene non-woven fabric.

The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.

V. Indication for Use

Item	Proposed Device (K202240)	Predicate Device (K160269)	Comparison
Trade Name	Disposable Surgical Mask/ Fluid Resistant Procedure Mask	Surgical Face masks (Ear loops and Tie-on)	-
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	Different²
Indication for Use	The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluids, and particulate material. These face masks are intended for use in infection control	The Surgical facemasks 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	Same

VI. Comparison of Technological Characteristics with the Predicate Devices

Table 1 General Comparison

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		practices to reduce thepotential exposure toblood and body fluids.This is a single-use,disposable device,provided non-sterile.	potential exposure toblood and body fluid.This is a single-use,disposable devicesprovided non-sterile.
Material	Innerlayer	Spun-bondpolypropylene	Polypropylene		Same
	Middlelayer	Melt blownpolypropylene filter	1. Polypropylenespun-bond2. Polypropylene meltblown		Different1
	Outerlayer	Spun-bondpolypropylene	Polypropylene		Same
	Earloops	88% Nylon + 12%Spandex	Ear loops: Polyester,polyurethane;Side tapes: Polyesterspun-bond (ear loopsmask only)Ties tapes:Polypropylenespun-bond or polyesterspun-bond		Different1
	Nosepiece	Iron wire covered bypolypropylene	Polyethylene coatedsteel wire		Different1
Color		Blue	Blue ,white		Different1
Length		17.5cm	17.5cm	18.0cm	Different2
Width		9.5cm	9.0cm	9.0cm
OTC Use		Yes	Yes		Same
Sterile		Non-sterile	Non-sterile		Same
Single for Use		Yes	Yes		Same
Fluid ResistancePerformanceASTM F1862		Pass at 160mmHg	Level 1: Pass at80mmHgLevel 2: Pass at120mmHgLevel 3: Pass at160mmHg		Different2

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ParticulateFiltrationEfficiencyASTM F2299	>99.9% at 0.1μm	≥98.0%
BacterialFiltrationEfficiencyASTM F2101	>99.9%	≥98%
DifferentialPressure	Average 3.52 mmH2O/cm²	Level 1: <5 mmH2O/cm²Level 2&3: <6 mmH2O/cm²
Flammability16 CFR 1610	Class 1Non Flammable	Class 1Non Flammable	Same
In VitroCytotoxicityISO 10993-5	Under the conditions ofthis study the device isnon-cytotoxic	Under the conditions ofthis study the device isnon-cytotoxic	Same
Skin IrritationISO 10993-10	Under the conditions ofthis study the device isnon-irritating	Under the conditions ofthis study the device isnon-irritating	Same
Skin SensitizationISO 10993-10	Under the conditions ofthis study the device isnon-sensitizing	Under the conditions ofthis study the device isnon-sensitizing	Same

Analysis:

1 The differences in the materials and color do not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation tests of the subject devices have been performed on the final finished device which includes all construction materials and color additives. The test results show pass the requirements.

2 The performances of proposed device have been performed the performance test according to method given in the ASTM F2100-19. The test results demonstrate that met the requirements in the standards. The minor difference between the proposed and predicate device does not affect the safety and effectiveness of the device.

VII. Summary of 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,

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which demonstrated that the proposed device complies with the related standards. Each type of performance testing used 32 samples in each of 3 non-consecutive lots (totally 96 samples).

Methodology/Standard	Purpose	AcceptanceCriteria	Results
ASTMF1862M-17	Fluid ResistancePerformance	29 out of 32 pass at160mmHg	Pass (95/96)
ASTM F2299	Particulate FiltrationEfficiency	≥98%	Pass (96/96)Average 99.9%at 0.1µm
ASTMF2101-19	Bacterial FiltrationEfficiency	≥98%	Pass (96/96)Average 99.9%
EN 14683:2019Annex C	Differential Pressure	<6mmH2O/cm²	Pass (96/96)Average 3.52mmH2O/cm²
16 CFR 1610	Flammability	Class INon Flammable	Pass (96/96)Meet Class I

Table 2 Performance Testing
-----------------------------	--

The biocompatibility of the proposed device was tested in accordance with ISO 10993 and passed acceptance criteria.

Test Items	Standard	Result
Cytotoxicity	ISO 10993-5:2009, BiocompatibilityEvaluation of Medical Device - Part 5:Tests for In Vitro Cytotoxicity	Under the conditions ofthe study, the subjectdevice wasnon-cytotoxic.
Skin irritation	ISO 10993-10:2010, BiocompatibilityEvaluation of Medical Device - Part 10:Tests for Irritation and Skin Sensitization	Under the conditions ofthe study, the subjectdevice was non-irritating.
SkinSensitization	ISO 10993-10:2010, BiocompatibilityEvaluation of Medical Device - Part 10:Tests for Irritation and Skin Sensitization	Under the conditions ofthe study, the subjectdevice wasnon-sensitizing.

Table 3 Biocompatibility Testing

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VIII. Clinical Testing

No clinical study is included in this submission.

IX. Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe, as effective and performs as well as the legally marketed predicate device.

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.