The Following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. These surgical masks are single use, disposable devices provided non-sterile.

3-ply EcoGuard B with Earloop, Model Number: ECO01
3-ply EcoGuard B with Tie-on, Model Number: ECO02

Device Description

The proposed surgical masks are available in two models with three-ply pleated earloop or tie-on (EcoGuard B) masks with ear loops and nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops or ties are held in place over the users' mouth and nose by two elastic ear loops or four ties welded to the surgical mask. Neither the elastic ear loops, nor ties are made with natural rubber latex. The nose piece in the layers of surgical mask is to allow the user to fit the surgical mask around their nose, which is made of malleable polyethylene wire. The surgical masks are sold nonsterile and are intended to be single use, disposable devices.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for a surgical mask (EcoGuard B). It assesses the substantial equivalence of the new device to a legally marketed predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and biocompatibility testing, not clinical studies involving human patients or complex AI algorithm evaluation.

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

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

Test	Purpose	Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%)	Reported Device Performance (EcoGuard B)	Average
ASTM F1862 Synthetic Blood Penetration	Determine synthetic blood penetration resistance	Level III (Pass at 160 mmHg)	Pass at 160 mmHg (95/96) (32 samples each from 3 lots)	N/A
ASTM F2101 Bacterial Filtration Efficiency	Determine the bacterial filtration efficiency	≥ 98%	Pass (96/96) (32 samples each from 3 lots)	99.9%
ASTM F2299 Particulate Filtration Efficiency at 0.1 micron	Determine submicron particulate filtration efficiency	≥ 99%	Pass (96/96) (32 samples each from 3 lots)	99.8%
Mil-M-36954C Delta P (Breathing Resistance)	Determine breathing resistance or differential pressure	< 6.0 mm H2O/cm2	Pass (96/96) (32 samples each from 3 lots)	4.4 mm H2O/cm2
16 CFR 1610 Flammability	Determine flammability or flame spread	Class 1	Class 1 Pass (96/96) (32 samples each from 3 lots)	N/A
Cytotoxicity	Assess cellular toxicity	Noncytotoxic	Pass (device is noncytotoxic)	N/A
Irritation	Assess skin irritation	Nonirritating	Pass (device is nonirritating)	N/A
Sensitization	Assess allergic sensitization	Nonsensitizing	Pass (device is nonsensitizing)	N/A

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

Sample Size for performance tests (ASTM F1862, F2101, F2299, Mil-M-36954C, 16 CFR 1610): 32 samples each from 3 non-consecutive lots (Total 96 samples per test).
Data Provenance: The document does not specify the country of origin where the testing was performed. The data is retrospective as it was collected and analyzed to support the 510(k) submission.

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

N/A. This document describes non-clinical performance and biocompatibility testing for a surgical mask, not clinical studies requiring expert ground truth for image or diagnostic interpretation. The "ground truth" for these tests are objective measurements based on specified industry standards.

4. Adjudication method for the test set

N/A. This is not applicable to the non-clinical and biocompatibility testing described.

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

N/A. This document pertains to a medical mask, not an AI-assisted diagnostic device. No MRMC study was performed.

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

N/A. This is not an AI algorithm. The performance tests are for the physical properties of the mask.

7. The type of ground truth used

The ground truth for the performance tests (e.g., filtration efficiency, blood resistance) are established and defined by the ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and other referenced standards (ASTM F1862, F2101, F2299, Mil-M-36954C, 16 CFR 1610). For biocompatibility, the ground truth is determined by the results of standardized biological tests (Cytotoxicity, Irritation, Sensitization) against established safety thresholds.

8. The sample size for the training set

N/A. This document describes the testing of a manufactured physical product (surgical mask), not a machine learning model. There is no concept of a "training set" in this context.

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

N/A. Not applicable for this type of device and testing.

Summary

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February 2, 2021

EcoGuard Inc. % Nickita Alexiades Consultant mdi Consultants. Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021

Re: K202096

Trade/Device Name: 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 5, 2021 Received: January 13, 2021

Dear Nickita Alexiades:

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 CAPT Elizabeth Claverie, M.S. 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) K202096

Device Name

3-ply EcoGuard B with Earloop; 3-ply EcoGuard B with Tie-on

Indications for Use (Describe)

3-ply EcoGuard B with Earloop, Model Number: ECO01 3-ply EcoGuard B with Tie-on, Model Number: ECO02

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

The assigned 510(k) number is: K202096.

1. Submitter's Identification:

Manufacturer: EcoGuard Inc. Address: 700 S BATTLEGROUND AVE, SUITES 103 GROVER, NC 28073

Contact Person: Ms. Fang Wang Ecoguard Inc.

Date Summary Prepared: January 29, 2021

Official Correspondent: Mr. Nickita Alexiades mdi Consultants, Inc.

2. Name of the Device:

Device Name(s):	3-ply EcoGuard B with Earloop,	Model Number: ECO01
Model Number(s):	3-ply EcoGuard B with Tie-on,	Model Number: ECO02

Common Name: Surgical Mask Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX

3. Information for the 510(k) Cleared Device (Predicate Device):

Predicate Device: Disposable Surgical Face Mask K153496 Xiantao Rayxin Medical Products Co., Ltd.

4. Device Description:

The proposed surgical masks are available in two models with three-ply pleated earloop or tie-on (EcoGuard B) masks with ear loops and nose piece. Detail configurations of them are presented in Table I: Surgical Masks Description.

Product Model Number:	Product Model	ASTM Level
ECO01	3-Ply EcoGuard B with Earloop	Level 3
ECO02	3-Ply EcoGuard B with Tie-On	Level 3

Table 1: Surqical Masks Description

The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops or ties are held in place over the users' mouth and nose by two elastic ear loops or four ties welded to the surgical mask. Neither the elastic ear loops, nor ties are made with natural rubber latex. The nose piece in the layers of surgical mask is to allow the user to fit the surgical

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mask around their nose, which is made of malleable polyethylene wire. The surgical masks are sold nonsterile and are intended to be single use, disposable devices.

5. Indications for Use:

The following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer of microorqanisms, body fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. These surgical masks are single use, disposable devices provided non-sterile.

3-ply EcoGuard B with Earloop, Model Number: ECO01 3-ply EcoGuard B with Tie-on, Model Number: ECO02

6. Comparison to the 510(k) Cleared Device (Predicate Device):

Item	Subject Device	Predicate Device	Similar or Different
Manufacturer	EcoGuard Inc.	Xiantao Rayxin Medical Products Co., Ltd.	-
510K number	K202096	K153496	-
Model Name	3-ply EcoGuard B with EarloopModel Number:ECO013-ply EcoGuard B with Tie-onModel Number:ECO02	Disposable Surgical Face Mask	Similar
Classification	Class II DeviceProduct Code: FXX(21 CFR878.4040)	Class II DeviceProduct Code: FXX(21 CFR878.4040)	Similar
Indications for Use	The Following EcoGuard 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 surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These surgical masks are single use, disposable	The Disposable 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 to blood and body fluids. This is a single use, disposable device(s), provided nonsterile.	Similar
	devices providednon-sterile.
Model(s) &Style	EcoGuard BEar LoopsFlat Pleated, 3 layersECO01Tie-OnFlat Pleated, 3 layersECO02	Ear LoopsTie-OnFlat Pleated3 layers	Similar
Outer FacingLayer	Spun-bondpolypropylene	Spun-bondpolypropylene	Similar
Middle Layer	Melt blownpolypropylene filter	Melt blownpolypropylene filter	Similar
Inner FacingLayer	Spun-bondpolypropylene	Spun-bondpolypropylene	Similar
Nose Piece	MalleablePolyethylene wire	Malleable Aluminumwire	Different
Ear Loops orTie-On	Earloops:PolyesterNylon/SpandexTie-On:Polypropylene	Earloops:Polyester	Similar
Color	Blue	Blue	Similar
Dimension(Width)	$17.5cm±2cm$$6.89" ± 0.40"$	$17.5cm±1cm$	Similar
Dimension(Length)	$9.5cm±2cm$$3.74" ± 0.40"$	$9.5cm±1cm$	Similar
OTC use	Yes	Yes	Similar
Sterility	Non-Sterile	Non-Sterile	Similar
Use	Single Use,Disposable	Single Use,Disposable	Similar
ASTM F2100Level	Level 3	Level 2	Similar
Non-ClinicalTesting	ASTM F1862ASTM F2299ASTM F2101ASTM F2100MIL-M369454C16 CFR 1610	ASTM F1862ASTM F2299ASTM F2101ASTM F2100MIL-M369454C16 CFR 1610	Similar
BiocompatibilityTesting	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization	Similar

Table 2: Comparison to Predicate Device

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The difference in the materials does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

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The EcoGuard Surgical Masks have been tested accordance with ASTM 2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks. See Table 2 for a summary of other non-clinical testing.

Test	Purpose	AcceptanceCriteria per ASTMF2100-11 Level 3(AQL = 4.0%)	Subject Device Test Results-EcoGuard B
			ASTM F2100-11Level 3	Average
ASTM F1862SyntheticBlood	Determinesyntheticbloodpenetrationresistance	Level III	Pass at 160mmHg (95/96)32 Sampleseach from 3 non-consecutive lots	N/A
ASTM F2101BFE	Determinethebacterialfiltrationefficiency	≥ 98%	Pass (96/96)32 Sampleseach from 3 non-consecutive lots	99.9%
ASTM F2299PFE at 0.1micron	Determinesubmicronparticulatefiltrationefficiency	≥ 99%	Pass (96/96)32 Sampleseach from 3 non-consecutive lots	99.8%
Mil-M-36954CDelta P	Determinebreathingresistanceordifferentialpressure	< 6.0 mmH2O/cm2	Pass (96/96)32 Sampleseach from 3 non-consecutive lots	4.4 mmH2O/cm2
16 CFR 1610Flammability	Determineflammabilityor flamespread	Class 1	Class 1 Pass(96/96)32 Sampleseach from 3 non-consecutive lots	N/A

	Table 2: Summary of Non-Clinical Testing

All testing results have met ASTM F2100-11 2019 Level 3 acceptance criteria. The testing information demonstrates that the safety and effectiveness of the EcoGuard B Surgical Masks in their intended environment of use is supported by testing that was conducted in accordance with the FDA 2004 guidance "Surgical Masks - Premarket Notification [510(k)] Submissions", which outlines performance requirements for surgical masks.

Test	Testing Findings	Result
Cytotoxicity(Standard)	Under the conditions of thestudy, the device isnoncytotoxic.	EcoGuard B: Pass
Irritation(Standard)	Under the conditions of thestudy, the device isnonirritating.	EcoGuard B: Pass
Sensitization(Standard)	Under the conditions of thestudy, the device isnonsensitizing	EcoGuard B: Pass

Table 3: Summary of Biocompatibility testing

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None of the biocompatibility testing results demonstrated any safety hazards or any design characteristics that violated the requirements set forth in the Guidance for Industry regarding Premarket Notification Submissions of Surgical Masks. It was our conclusion that both 3-ply EcoGuard B with Earloop and 3-ply EcoGuard B with Tie-on surgical masks met all relevant testing requirements.

8. Discussion of Clinical Tests Performed:

No Clinical testing was performed.

9. Conclusions:

Based on the comparison and analysis above and the nonclinical tests performed, the subject device, EcoGuard B Surgical Masks, are as safe, as effective, and performs as well as the legally marketed predicate device, Xianto Rayxin Medical Products Disposable Surgical Mask cleared under K153496.

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.