The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

Device Description

The subject device includes six mask models. Each mask is composed of four-layers (outer non-woven layer, support layer, melt blown filter layer, and inner non-woven layer). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The masks are single use, disposable devices, provided non-sterile. These devices are not made from Natural Rubber Latex.

AI/ML Overview

The provided text is a 510(k) summary for surgical masks, not an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding AI/ML performance metrics, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.

However, I can extract the acceptance criteria and non-clinical study results for these surgical masks, as presented in the document.

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Surgical Masks)

The non-clinical tests were conducted to verify that the proposed device met design specifications and complied with relevant standards. The tests align with ASTM F2100 Level 3 barrier requirements.

Performance Testing	Test Methodology	Acceptance Criteria: Level 3 Barrier	Reported Device Performance
Particulate Filtration Efficiency (PFE)	ASTM F2299-17	≥98%	Passed at ≥ 98% @ 0.1 micron
Fluid Resistance	ASTM F1862-17	Pass at 160 mmHg	Passed at 160mm Hg
Bacterial Filtration Efficiency (BFE)	ASTM F2101-19	≥98%	Passed at ≥ 98%
Differential Pressure (Breathability)	EN 14683:2019 Annex C	<6 mmH2O/cm²	Passed at < 6.0 mm H2O/cm²
Flammability	16 CFR Part 1610-2008	Class 1	Passed: Class 1

Biocompatibility Testing

Biocompatibility Evaluation	Test Methodology	Acceptance Criteria	Reported Device Performance
In Vitro Cytotoxicity Test	ISO 10993-5: 2009	Non-cytotoxic	Non-cytotoxic
Skin Sensitization Test	ISO 10993-10: 2010	Non-sensitizing	Non-sensitizing
Skin Irritation Test	ISO 10993-10: 2010	Non-irritating	Non-irritating
Systemic Toxicity Test (Acute Systemic Toxicity)	ISO 10993-11: 2017	Non-acute systemic toxicity	Non-acute systemic toxicity

Information Not Applicable to This Document (AI/ML-specific questions):

Sample size used for the test set and the data provenance: Not applicable. This document describes physical device testing, not data-driven AI model testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for masks is established by standardized laboratory testing.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Standardized physical and biological test methods defined by ISO and ASTM standards (e.g., measuring filtration efficiency, fluid resistance, cellular response).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 24, 2022

The GOOD Corporation % Mikael Hellstrand RA Manager K-Bio Solutions 201 South 4th St. Suite 727 San Jose, California 95112

Re: K211771

Trade/Device Name: The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 20, 2022 Received: July 25, 2022

Dear Mikael Hellstrand:

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

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

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 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 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,

Bifeng Qian, M.D., 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) K211771

Device Name

Indications for Use (Describe)

Device Name (Model Number):

The GOOD High Fluid-Resistant Surgical Mask (202001629)

The GOOD High Fluid-Resistant Surgical Procedure KF Mask (201703328)

The GOOD Super Guard Design High Fluid-Resistant Surgical Mask (201801049)

The KOEASY High Fluid-Resistant Surgical Mask (202002107)

The KOEASY High Fluid-Resistant Surgical Procedure KF Mask (201905891)

The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask (201905443)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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The assigned 510(k) Number: K211771

510(k) Summary

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

1. Submitter's Information

Sponsor Name: The GOOD Corporation Address: 47-13 Eoso 3-gil, Cheongbuk-eup, Pyeongtaek-si, Gyeonggi-do, Republic of Korea Postal Code: 17795 Contact Name: Hak Rae Lee Tel: +82-31-684-9812 Fax: +82-31-684-9813 E-mail: hr.lee@thegoodas.com

Application Correspondent:

Contact Person: Mr. Mikael Hellstrand Company: K-Bio Solutions Address: 201 South 4th St, Suite 727, San Jose, CA95112, USA Tel: USA: 408-750-7843, KOR: +82-10-7103-0993 E-mail: mikael(@)kbiotechsolutions.com

2. Date of the summary prepared: August 24, 2022

3. Subject Device Information

Type of 510(k): Traditional Trade Name: The GOOD High Fluid-Resistant Surgical Mask The GOOD High Fluid-Resistant Surgical Procedure KF Mask The GOOD Super Guard Design High Fluid-Resistant Surgical Mask The KOEASY High Fluid-Resistant Surgical Mask The KOEASY High Fluid-Resistant Surgical Procedure KF Mask The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask Classification Name: Mask, Surgical Review Panel: General Hospital Product Code: FXX Regulation: 21 CFR 878.4040 - Surgical Apparel Regulatory Class: Class II

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4. Predicate Device Information

Sponsor: 3M Health Care Trade Name: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask Classification Name: Mask, Surgical 510(k) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: Class II

5. Device Description

The subject device includes six mask models, which are listed in Table 5.0-1 below.

No.	Device Name	ModelNumber
1	The GOOD High Fluid-Resistant Surgical Mask	202001629
2	The GOOD High Fluid-Resistant Surgical Procedure KF Mask	201703328
3	The GOOD Super Guard Design High Fluid-Resistant Surgical Mask	201801049
4	The KOEASY High Fluid-Resistant Surgical Mask	202002107
5	The KOEASY High Fluid-Resistant Surgical Procedure KF Mask	201905891
6	The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask	201905443

Table 5.0-1: Subject Device Names and Model Numbers

Each mask is composed of four-layers (outer non-woven layer, support layer, melt blown filter layer, and inner non-woven layer). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The masks are single use, disposable devices, provided non-sterile. These devices are not made from Natural Rubber Latex.

The GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), GOOD Design Mask (201801049) share the same dimensions as shown in Table 5.0-2 below. The KOEASY Surgical Mask (202002107), KOEASY KF Mask (201905891), KOEASY Design Mask (201905443) share the same dimensions as shown in Table 5.0-2 below.

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Table 5.0-2: Dimensions of the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), GOOD Design Mask (201801049), KOEASY Surgical Mask (202002107), KOEASY KF Mask (201905891), and KOEASY Design Mask (201905443)

No.	Device Name	ModelNumber	Dimensions
1	The GOOD High Fluid-Resistant Surgical Mask	202001629	Mask Length: 210mmMask Width: 85mm
2	The GOOD High Fluid-Resistant Surgical Procedure KF Mask	201703328
3	The GOOD Super Guard Design High Fluid-Resistant Surgical Mask	201801049
4	The KOEASY High Fluid-Resistant Surgical Mask	202002107	Mask Length: 220mmMask Width: 80mm
5	The KOEASY High Fluid-Resistant Surgical Procedure KF Mask	201905891
6	The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask	201905443

The similarities and differences between the six masks in terms of the mask components are provided in Table 5.0-3 below.

Table 5.0-3: Components of the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), GOOD Design Mask (201801049), KOEASY Surgical Mask (202002107), KOEASY KF Mask (201905891), and KOEASY Design Mask (201905443)

Component	Component Description	The GOODHigh Fluid-ResistantSurgical Mask(202001629)	The GOODHigh Fluid-ResistantSurgicalProcedure KFMask(201703328)	The GOODSuper GuardDesign HighFluid-ResistantSurgical Mask(201801049)	The KOEASYHigh Fluid-ResistantSurgical Mask(202002107)	The KOEASYHigh Fluid-ResistantSurgicalProcedure KFMask(201905891)	The KOEASYSuper GuardDesign HighFluid-ResistantSurgical Mask(201905443)
MaskComponents	Outer Non-Woven Layer	●	●	●	●	●	●
	Support Layer	●	●	●	●	●	●
	Melt Blown Filter Layer	●	●	●	●	●	●
	Inner Non-Woven Layer	●	●	●	●	●	●
	Ear String	●	●	●	●	●	●
	Nose Support	●	●	●	●	●	●
	Colorant (Magenta,Yellow, Cyan, Black)		●	●
PolypropyleneMelt BlownFilter Density	Polypropylene MeltBlown Filter Density:20mg/m2			●	●
	Polypropylene MeltBlown Filter Density:30mg/m2					●	●

= Applicable component that is included in each mask model

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The GOOD Design Mask (201801049) and the KOEASY Design Mask (201905443) share the same components and raw materials as shown in Table 5.0-4 below.

Table 5.0-4: Identical Components and Raw Materials for both the GOOD Design Mask
(201801049) and the KOEASY Design Mask (201905443)

No.	Component Namefor both the 201801049 and201905443 models.	Raw Material Chemical Namefor both the 201801049 and 201905443 models.
1	Outer Non-Woven Fabric	Titanium dioxide
		Polyethylene terephthalate
		Amaranth
		Tartrazine
		Brilliant Blue FCF
		Naphthol Blue Black
		Glycerol
2	Support Layer	Polyethylene
		Polypropylene
3	Melt Blown Filter Layer	Polypropylene
		Titanium dioxide
4	Inner Non-Woven Fabric	Polypropylene
		Polyethylene
5	Ear String	Nylon
		Nylon 6
		Carbon Black
6	Nose Support	Polyurethane
		Polyethylene
		Polyethylene terephthalate
		Iron

The only difference between the GOOD Design Mask (201801049) and the KOEASY Design Mask (201905443) are identified below as dimensional differences:

GOOD Design Mask (201801049): Length: 210mm, Width: 85mm ●
KOEASY Design Mask (201905443): Length: 220mm, Width: 80mm ●

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The GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), KOEASY Surgical Mask (202002107), and KOEASY KF Mask (201905891) share the same components and raw materials as shown in Table 5.0-5 below.

Table 5.0-5: Identical Components and Raw Materials for the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), KOEASY Surgical Mask (202002107), and KOEASY KF Mask (201905891)

No.	Component Namefor the 202001629, 201703328,202002107, and 201905891 models.	Raw Material Chemical Namefor the 202001629, 201703328,202002107, and 201905891 models.
1	Outer Non-Woven Layer	Titanium dioxidePolypropylene
2	Support Layer	PolyethylenePolypropylene
3	Melt Blown Filter Layer	PolypropyleneTitanium dioxide
4	Inner Non-Woven Layer	PolypropylenePolyethylene
5	Ear String	Nylon 6Polyurethane
6	Nose Support	PolyethylenePolyethylene terephthalateIron

The only difference between the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), KOEASY Surgical Mask (202002107), and KOEASY KF Mask (201905891) are identified below as dimensional differences:

GOOD Surgical Mask (202001629): Length: 210mm, Width: 85mm .
GOOD KF Mask (201703328): Length: 210mm, Width: 85mm ●
KOEASY Surgical Mask (202002107): Length: 220mm, Width: 80mm ●
KOEASY KF Mask (201905891): Length: 220mm, Width: 80mm ●

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6. Indications for Use

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7. Comparison to Predicate Device

The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

ComparisonItem	Proposed Device	Predicate Device	Note
Manufacturer	The GOOD Corporation	3M Health Care	--
510(k)	K211771	K191355	--
Trade Name	• The GOOD High Fluid-Resistant Surgical Mask• The GOOD High Fluid-Resistant Surgical ProcedureKF Mask• The GOOD Super GuardDesign High Fluid-ResistantSurgical Mask• The KOEASY High Fluid-Resistant Surgical Mask• The KOEASY High Fluid-Resistant Surgical ProcedureKF Mask• The KOEASY Super GuardDesign High Fluid-ResistantSurgical Mask	3M™ High Fluid-ResistantSurgical Mask	--
Model	• 202001629• 201703328• 201801049• 202002107• 201905891• 201905443	• 1835• 1835FS	--
ClassificationName	Mask, Surgical	Mask, Surgical	Same
Classification	Class II	Class II	Same
Product Code	FXX	FXX	Same
Indicationsfor Use/Intended Use	The GOOD High Fluid-Resistant Surgical Mask and theKOEASY High Fluid-ResistantSurgical Mask are intended to beworn to protect both the patient	3M™ High Fluid-ResistantSurgical Mask is intended to beworn to protect both the patientand healthcare personnel fromtransfer of microorganisms	Same

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	and healthcare personnel from	body fluids, and particulate
	transfer of microorganisms,	material. These face masks are
	body fluids, and particulate	intended for use in infection
	material. These face masks are	control practices to reduce
	intended for use in infection	potential exposure to blood and
	control practices to reduce	body fluids. This is a single
	potential exposure to blood and	use, disposable device,
	body fluids. The face mask is	provided non-sterile.
	single use, disposable device,
	provided non-sterile.
	Materials (Model 202001629, 201703328, 202002107, and 201905891)
Outer Non-	Titanium dioxide	Polypropylene Spunbond,	Different
Woven Layer	Polypropylene	green	Note 1
Support	Polyethylene	Polypropylene Spunbond,	Different
Layer	Polypropylene	white	Note 1
Melt Blown	Polypropylene	Polypropylene Meltblown,	Same
Filter Layer	Titanium dioxide	white
Inner Non-	Polypropylene	Polypropylene Thermalbonded,	Different
Woven Layer	Polyethylene	white	Note 1
Nose Support	Polyethylene	Polyethylene Coated Steel	Different
	Polyethylene terephthalate	Wire	Note 1
	Iron
Edge Wrap	Not Applicable	Polypropylene Spunbond,	Different
		white or Polyethylene	Note 2
		Terephthalate, white
Ear Strings	Nylon 6	Not Applicable	Different
	Polyurethane		Note 1
Tie Strings	Not Applicable	Polypropylene Spunbond,	Different
		white or Polyethylene	Note 3
		Terephthalate, white
Materials (Model 201801049 and 201905443)
Outer Non-	Titanium dioxide	Polypropylene Spunbond,	Different
Woven Layer	Polyethylene terephthalate	green	Note 1
	Amaranth		and
	Tartrazine		Note 4
	Brilliant Blue FCF
	Naphthol Blue Black

	Glycerol

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SupportLayer	PolyethylenePolypropylene	Polypropylene Spunbond,white	DifferentNote 1
Melt BlownFilter Layer	PolypropyleneTitanium dioxide	Polypropylene Meltblown,white	Same
Inner Non-Woven Layer	PolypropylenePolyethylene	Polypropylene Thermalbonded,white	DifferentNote 1
Nose Support	PolyethylenePolyethylene terephthalateIron	Polyethylene Coated SteelWire	DifferentNote 1
Edge Wrap	Not Applicable	Polypropylene Spunbond,white or PolyethyleneTerephthalate, white	DifferentNote 2
Ear Strings	NylonNylon 6Carbon BlackPolyurethane	Not Applicable	DifferentNote 1andNote 4
Tie Strings	Not Applicable	Polypropylene Spunbond,white or PolyethyleneTerephthalate, white	DifferentNote 3
Design Features
Colors	Model 202001629,201703328, 202002107, and201905891: White. Model 201801049 and201905443: Magenta,Yellow, Cyan, and Black.	Green (Outer)	DifferentNote 4
Style	Flat - Pleated	Flat - Pleated	Same
MultipleLayers	Yes	Yes	Same
Single Use	Yes	Yes	Same
Sterility
Sterile	Non-Sterile	Non-Sterile	Same
Dimensions
Length	Model 202001629,201703328, and 201801049:210mm. Model 202002107,201905891, and 201905443:220mm.	6.9" ± 0.2" (175.26mm ±5.08mm)	DifferentNote 5
Width	Model 202001629,201703328, and 201801049:85mm. Model 202002107,201905891, and 201905443:80mm.	3.5" ± 0.3" (88.9mm ±7.62mm)	DifferentNote 5
Technological Characteristics Product Barrier Specifications Per ASTM F2100 – MeetsLevel 3
ParticulateFiltrationEfficiency(PFE)	Passed at ≥ 98% @ 0.1 micron(ASTM F2299)	Passed at ≥98% @ 0.1 micron(ASTM F2299)	Same
FluidResistance	Passed at 160mm Hg(ASTM F1862)	Passed at 160mm Hg(ASTM F1862)	Same
BacterialFiltrationEfficiency(BFE)	Passed at ≥ 98%(ASTM F2101)	Passed at ≥98%(ASTM F2101)	Same
DifferentialPressure	Passed at < 6.0 mm H2O/cm2(EN 14683:2019 Annex C)	Passed at <5 mmH2O/cm2(MIL-M36954C)	DifferentNote 6
Flammability	Passed: Class 1(16 CFR Part 1610)	Passed ≥3 Seconds burn time -Class 1(16 CFR Part 1610)	Same
Biocompatibility
In VitroCytotoxicityTestISO 10993-5:2009	Non-cytotoxic	Non-cytotoxic	Same
SkinSensitizationTestISO 10993-10:2010	Non-sensitizing	Non-sensitizing	Same
SkinIrritation TestISO 10993-10:2010	Non-irritating	Non-irritating	Same
SystemicToxicity Test	Non-acute systemic toxicity	Not Applicable	DifferentNote 7
ISO 10993-11: 2017

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Comparison in Detail(s):

Note 1: Raw Material - Substantial Equivalence Assessments

The patient contacting material for the proposed device is different from predicate device. However, biocompatibility testing per ISO 10993 series standard requirements has been performed on the proposed device and the results does not show any toxicity effect. Performance testing with ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) has also been performed on the proposed device and the results show "pass" with meeting Level 3 requirements. Thus, this difference in materials is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).

Note 2: Edge Wrap Component - Substantial Equivalence Assessments

The proposed device does not contain the "Edge Wrap" component of the predicate device. However, the "Edge Wrap" material of the predicate device, "Polypropylene Spunbond, white or Polyethylene Terephthalate, white" is the identical polypropylene or polyethylene terephthalate material that is included in mask layers of the proposed device.

Without the predicate component of the Edge Wrap, the proposed device was evaluated . with Performance testing with FDA's recognized standard of ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) with all favorable test results showing "pass" with meeting Level 3 requirements.
As such, the minor difference of not having the "Edge Wrap" is not expected to raise ● different questions of safety and effectiveness compared to the predicate (K191355).

Note 3: Tie Strings Component - Substantial Equivalence Assessments

The predicate device is available in two types, ear string type and tie string type. The proposed device is provided in only the ear string type. Despite the absence of tie strings, tight securing with ear strings of the proposed device to the user's face. mouth, and nose is achieved as demonstrated with the favorable test results under the FDA's recognized standard of ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks). Thus, this difference is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).

Note 4: Colors - Substantial Equivalence Assessments

Colors for the proposed device is different from predicate device. However, biocompatibility testing per ISO 10993 series standard requirements has been performed on the proposed device and the results does not show any toxicity effect. Performance testing with ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) has also

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been performed on the proposed device and the results show "pass" with meeting Level 3 requirements. Thus, this difference in colors is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).

Note 5: Dimensions - Substantial Equivalence Assessments

Dimensions for the proposed device is different from the predicate device. However, performance testing with ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) has been performed on the proposed device and the results show "pass" with meeting Level 3 requirements. Thus, this difference in dimensions is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).

Note 6: Differential Pressure - Substantial Equivalence Assessments

The differential pressure test reference used for the proposed device and the predicate device are not the same references; the differential pressure testing for the proposed device was conducted according to "EN 14683:2019 Annex C: Method for Determination of Breathability", while the differential pressure testing for the predicate device was conducted according to "MIL-M36954C: Military Specification-Mask, Surgical, Disposable".

The differential pressure testing for the proposed device was appropriately completed for . EN 14683:2019 Annex C. The EN 14683:2019 Annex C is the one of the mask performance standards specified in ASTM F2100-19. ASTM F2100-19 is the FDA's recognized consensus standard [FDA Recognition Number 6-425] which is the standard specification for performance of materials used in medical face masks.
Thus, the standard reference difference of "EN 14683:2019 Annex C (Test Criteria: < 6.0 ● mm H2O/cm²) versus "MIL-M36954C (Test Criteria: < 5.0 mm H2O/cm²)" is not assessed to raise different questions in terms of the safety and effectiveness compared to the predicate device.

Note 7: Non-acute Systemic Toxicity Testing - Substantial Equivalence Assessments

Non-acute systemic toxicity biocompatibility testing per ISO 10993-11 has been performed on the proposed device and the results does not show any toxicity effect.

. However, non-acute systemic toxicity biocompatibility testing per ISO 10993-11 was not performed on the predicate device.
The non-acute systemic toxicity biocompatibility testing per ISO 10993-11 performed on . the proposed device does not raise different questions in terms of the safety and effectiveness compared to the predicate device.

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8. Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions issued on March 5, 2004:

ISO 10993-05:2009 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
ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
ASTM F2100, 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, Medical Face Masks Requirements and Test Methods
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
ASTM F2299, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
16 CFR 1610, Standard for the Flammability of Clothing Textiles

Performance Testing
Test Methodology	Purpose	ASTM F2100-19Acceptance Criteria:Level 3 Barrier	Result
Particulate FiltrationEfficiency (PFE)ASTM F2299-17	Measure initial particlefiltration efficiency	≥98%	Passed
Fluid ResistanceASTM F1862-17	Evaluate the resistance topenetration by impact ofsmall volume of syntheticblood	Pass at 160 mmHg	Passed
Bacterial FiltrationEfficiency (BFE)ASTM F2101-19	Measure bacterial filtrationefficiency	≥98%	Passed

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Differential Pressure(mmH2O/cm2)EN 14683:2019 Annex C	Determine breathability ofthe mask	<6 mmH2O/cm²	Passed
Flammability16 CFR Part 1610-2008	Response of materials toheat and flame	Class 1	Passed

Biocompatibility Testing

According to ISO 10993-1: 2018, the nature of body contact for the subject device is Surface Device category, Intact Skin Contact and duration of contact is B - prolonged (>24h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

Biocompatibility Evaluation
Test Methodology	Purpose	Acceptance Criteria	Result
ISO 10993-5: 2009Biological Evaluation ofMedical Devices – Part5: Tests for In VitroCytotoxicity.	Verify the Cytotoxicitypotential of the subjectdevice	Non-cytotoxic	Passed
ISO 10993-10: 2010Biological Evaluation ofMedical Devices – Part10: Tests for Irritationand Skin Sensitization.	Verify the Sensitizationpotential of the subjectdevice	Non-sensitizing	Passed
ISO 10993-10: 2010Biological Evaluation ofMedical Devices – Part10: Tests for Irritationand Skin Sensitization.	Verify the Irritationpotential of the subjectdevice	Non-irritating	Passed
ISO 10993-11: 2017Biological Evaluation ofMedical Devices – Part11: Tests for SystemicToxicity.	Verify the Acute SystemicToxicity potential of thesubject device	Non-acute systemictoxicity	Passed

9. Summary of Clinical Testing

No clinical study is included in this submission.

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10. Final Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicated device, 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, cleared under K191355.

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.