Surgical Face 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Device Description

The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.

AI/ML Overview

The information provided describes the acceptance criteria and performance of a Surgical Face Mask (K202708), comparing it to a predicate device (K201729).

Here's a breakdown of the requested information:

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

Criteria	Acceptance Criteria (Predicate/Standard)	Reported Device Performance (K202708)	Outcome
Fluid Resistance (ASTM F1862)	Fluid Resistant at 80 mmHg	Lot 20201013: Passed 80 mmHgLot 20201022: Passed 80 mmHgLot 20201105: Passed 80 mmHg	Meets
Particulate Filtration Efficiency (PFE) (ASTM F2299)	≥ 95%	Lot 20201013: PASSED 99.866%Lot 20201022: PASSED 99.9784%Lot 20201105: PASSED 99.9879%	Meets (Exceeds)
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	≥ 95%	Lot 20201013: PASSED 99.9%Lot 20201022: PASSED 99.9%Lot 20201105: PASSED 99.9%	Meets (Exceeds)
Differential Pressure (EN 14683 Annex C)	< 5.0 mmH2O/cm²	Lot 20201013: Average 3.9 mmH2O/cm²Lot 20201022: Average 3.9 mmH2O/cm²Lot 20201105: Average 4.2 mmH2O/cm²	Meets
Flammability (16 CFR 1610)	Class 1	Lot 20201013: IBE (Class 1)Lot 20201022: IBE (Class 1)Lot 20201105: IBE (Class 1)	Meets
Biocompatibility (Cytotoxicity) (ISO 10993-5)	No cytotoxicity	Non-cytotoxic	Meets
Biocompatibility (Sensitization) (ISO 10993-10)	No sensitization	Non-sensitizing	Meets
Biocompatibility (Irritation) (ISO 10993-10)	No irritation	Non-irritating	Meets

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

The document references "32/32" or similar notations for the lots tested for PFE, BFE, and Fluid Resistance. This likely indicates that all 32 samples from each lot tested met the criteria for these specific tests. However, the precise definition of "sample" in this context (e.g., individual masks, or a batch from which tests are performed) and the overall sample size for each test (e.g. how many masks in total were subjected to fluid resistance) and lot are not explicitly stated in granular detail beyond the "32/32" type notation.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, although the manufacturer is INTCO Medical (HK) Co., Ltd.

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 as the device is a surgical face mask and the testing performed is for physical and biological properties in accordance with established ASTM, EN, and ISO standards, not for diagnostic accuracy requiring expert consensus.

4. Adjudication method for the test set

This information is not applicable as the evaluation is based on objective, standardized laboratory tests, not subjective interpretations requiring adjudication.

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

This information is not applicable. The device is a surgical face mask, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted.

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

This information is not applicable. The device is a surgical face mask, not an AI-powered algorithm.

7. The type of ground truth used

The ground truth for the performance criteria is based on established industry standards and regulatory requirements (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the acceptable range or threshold for each performance characteristic.

8. The sample size for the training set

This information is not applicable. The device is a passive medical device (surgical face mask), not a machine learning model, so there is no training set in the AI sense.

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

This information is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

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.

March 30, 2021

Intco Medical(HK) Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K202708

Trade/Device Name: Surgical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 19, 2021 Received: March 22, 2021

Dear Prithul Bom:

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.

{1}------------------------------------------------

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 (OS) 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,

For 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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202708

Device Name 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo and address of INTCO Medical (HK) Co., Ltd. The logo features the company name in blue, with a stylized graphic of a sun or flower above it. The address is listed as Flat/RM 19c, Lockhart Centre 301-307 Lockhart road, Wan Chai, Hong Kong.

K202708

510(K) SUMMARY

1. Submitter's Identification:

INTCO Medical (HK) Co., Ltd. Flat/RM 19c, Lockhart Centre 301-307 Lockhart road, Wan Chai, Hong Kong

Contact Person:

Max Li Product Manager Phone number: 86-511-83174088 Fax: 86-511-83174188 Email: maxli@intco.com

Date summary prepared:

March 30, 2021

1. Device Name: Surgical Face Masks Trade Name: Surgical Face Mask
1. Device Classification Name: Mask, Surgical (21 CFR 878.4040) Device Classification Panel: General Hospital
1. Device Class: Class II
1. Product Code: FXX Mask, Surgical

{4}------------------------------------------------

6. Predicate Device:

Zhende Medical Co., Ltd. ● Medical Mask(K201729)

7. Reason for 510(k) Submission:

New device.

8. Device Description:

9. Intended Use/Indications for Use:

{5}------------------------------------------------

Feature	(Proposed Device)Surgical Face Masks	(Predicate Device)K201729	Remarks
510(K) #	Proposed DeviceK202708	K201729	Proposed device issame as or similar tothe primary predicate
Manufacturer	INTCO Medical(HK) Co., Ltd.	Zhende Medical CoLtd.	NA
Common Name	Surgical Face Mask	Medical Mask	Common name of theproposed device issimilar to the predicatedevice
Classification	Class II	Class II	Device class of theproposed device is thesame as the predicatedevice
Product Code	FXX	FXX	Product code of theproposed device is thesame as the predicatedevice
Intended Use	Surgical Face Masksare intended to be wornto protect both thepatient and healthcarepersonnel from transferof microorganisms,body fluids andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure ofthe wearer to blood and	The Medical Masks areintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure ofthe wearer to blood andbody fluids. This is a	The intended use of theproposed device is thesame as the predicatedevice.
	body fluids. This is asingle use, disposabledevice(s), providednon-sterile.	single use, disposabledevice(s), providednon-sterile.
Materials
Outer Layer	PolypropyleneSpunbondColor: Blue	Spun-bondPolypropyleneColor: Blue	Materials of theproposed device are thesame as or similar tothe predicate device
Inner Layer	PolypropyleneSpunbond	Spun-bondPolypropylene
Filter Media Layer	PolypropyleneMeltblown	Melt BlownPolypropylene filter
Ear Loops	Ear loops:Polyester/lycra knittedDiameter: 0.3 cmLength: 17.5 cm.	Ear loops:Polyester/Spandex
Nosepiece	Malleable aluminumstripWidth: 0.3 cmLength: 10 cm	Malleablepolypropylene with ironwire
Specifications andDimensions	Length: 165 ± 19 mmWidth: 102 ± 19 mm	Length: 180 ± 10 mmWidth: 95 ± 10 mm	Specifications anddimensions of theproposed device aresimilar to the predicatedevice
Mask Style	Flat pleated	Flat pleated	The mask style of theproposed device is thesame as the predicatedevice
Sterility	Non-sterile	Non-sterile	The proposed productand predicate device arenon-sterile.
ASTM F2100Level	Level 1	Level 1	The proposed productand predicate devicehave the same ASTMF2100 Level
PerformanceTesting(Completed)
Fluid Resistance	Fluid Resistant at 80mmHgLot 20201013 31/32Passed 80 mmHgLot 20201022 32/32Passed 80 mmHgLot 20201105 32/32Passed 80 mmHgASTM F1862	Fluid Resistant at 80mmHgASTM F1862	Fluid resistantperformance of theproposed device is thesame as the predicatedevice
Particulate FiltrationEfficiency (PFE)	Lot 20201013 32/32PASSED 99.866%Lot 20201022 32/32PASSED 99.9784%Lot 20201105 32/32PASSED 99.9879%ASTM F2299	≥ 95%ASTM F2299	Particulate FiltrationEfficiency performanceof the proposed deviceis similar to thepredicate device
Bacterial FiltrationEfficiency (BFE)	Lot 20201013 32/32PASSED 99.9%Lot 20201022 32/32PASSED 99.9%Lot 20201105 32/32PASSED 99.9%ASTM F2101	≥ 95%ASTM F2101	Bacterial FiltrationEfficiency performanceof the proposed deviceis similar to thepredicate device
Differential Pressure	< 5.0mmH2O/cm²Lot 20201013Average 3.9mmH2O/cm²Lot 20201022	< 5.0mmH2O/cm²EN 14683 Annex C	Differential Pressureperformance of theproposed device is thesame as the predicatedevice

	Average 3.9mmH2O/cm²Lot 20201105Average 4.2mmH2O/cm²EN 14683 Annex C
Flammability	Class 1Lot 20201013 IBELot 20201022 IBELot 20201105 IBE16 CFR 1610	Class 116 CFR 1610	Flammabilityperformance of theproposed device is thesame as the predicatedevice



Biocompatibility	Under the conditions ofthe study, the device isnon-cytotoxicISO 10993-5Under the conditions ofthe study, the device isnon-sensitizingISO 10993-10Under the conditions ofthe study, the device isnon-irritatingISO 10993-10	No cytotoxicityISO 10993-5No sensitizationISO 10993-10No IrritationISO 10993-10	Biocompatibilityperformance of theproposed device is thesame as the predicatedevice

Comparison between the device and predicate device:

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

11. Non-Clinical Tests Performed

ASTM 2100, 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 Syntehtic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);

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 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus;

EN 14683 Annex C, Medical Face Masks - Requirements and Test Methods;

16 CFR 1610, Standard for Flammability of clothing textiles;

ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation And Skin Sensitization

12. Clinical Test Performed

No clinical testing was performed.

{9}------------------------------------------------

13. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202708, FXX, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201729.

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.