Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple surgical mask with no mention of AI/ML in its description, intended use, or performance studies.

Therapeutic

No.
Explanation: The device is a surgical mask intended for infection control to protect against the transfer of microorganisms, body fluids, and particulate material, not for treating a disease or condition.

Diagnostic

No
The device, a surgical mask, is intended to protect against the transfer of microorganisms and particulate material, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of materials like polypropylene and polyethylene wire, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
Device Function: The description clearly states the surgical masks are intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate material. They act as a physical barrier.
Intended Use: The intended use is for infection control practices by reducing exposure to blood and bodily fluid, not for analyzing biological samples.
Device Description: The description focuses on the physical construction and materials of the mask, not on any components that would interact with or analyze biological specimens.
Performance Studies: The performance studies listed (blood penetration, BFE, PFE, Delta P, flammability, biocompatibility) are all related to the physical barrier properties and safety of the mask when worn, not to diagnostic capabilities.

The device described is a surgical mask, which is a type of personal protective equipment (PPE) and a medical device, but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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

Product codes

FXX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests Performed for Determination of Substantial Equivalence:
The EcoGuard Surgical Masks have been tested accordance with ASTM 2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks.
Tests included:

ASTM F1862 Synthetic Blood Penetration Resistance: Pass at 160 mmHg (95/96) 32 Samples each from 3 non-consecutive lots.
ASTM F2101 BFE (Bacterial Filtration Efficiency): Pass (96/96) 32 Samples each from 3 non-consecutive lots, Average 99.9%.
ASTM F2299 PFE at 0.1 micron (Submicron Particulate Filtration Efficiency): Pass (96/96) 32 Samples each from 3 non-consecutive lots, Average 99.8%.
Mil-M-36954C Delta P (Breathing Resistance or Differential Pressure): Pass (96/96) 32 Samples each from 3 non-consecutive lots, Average 4.4 mm H2O/cm2.
16 CFR 1610 Flammability: Class 1 Pass (96/96) 32 Samples each from 3 non-consecutive lots.

All testing results have met ASTM F2100-11 2019 Level 3 acceptance criteria.

Biocompatibility Testing:

Cytotoxicity (Standard): Under the conditions of the study, the device is noncytotoxic. Result: EcoGuard B: Pass.
Irritation (Standard): Under the conditions of the study, the device is nonirritating. Result: EcoGuard B: Pass.
Sensitization (Standard): Under the conditions of the study, the device is nonsensitizing. Result: EcoGuard B: Pass.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Bacterial Filtration Efficiency (BFE): Average 99.9% (acceptance criteria >= 98%)
Particulate Filtration Efficiency (PFE) at 0.1 micron: Average 99.8% (acceptance criteria >= 99%)
Differential Pressure (Delta P): Average 4.4 mm H2O/cm2 (acceptance criteria

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.

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)

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

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

4

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 Earloop
Model Number:
ECO01

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 | Acceptance
Criteria per ASTM
F2100-11 Level 3
(AQL = 4.0%) | Subject Device Test Results-
EcoGuard B | |
|------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------|
| | | | ASTM F2100-11
Level 3 | Average |
| ASTM F1862
Synthetic
Blood | Determine
synthetic
blood
penetration
resistance | Level III | Pass at 160
mmHg (95/96)
32 Samples
each from 3 non-
consecutive lots | N/A |
| ASTM F2101
BFE | Determine
the
bacterial
filtration
efficiency | ≥ 98% | Pass (96/96)
32 Samples
each from 3 non-
consecutive lots | 99.9% |
| ASTM F2299
PFE at 0.1
micron | Determine
submicron
particulate
filtration
efficiency | ≥ 99% | Pass (96/96)
32 Samples
each from 3 non-
consecutive lots | 99.8% |
| Mil-M-
36954C
Delta P | Determine
breathing
resistance
or
differential
pressure |