ECOMA Level 2 Disposable Surgical Mask with Ear Loops

• K Number: K210698
• Device Name: ECOMA Level 2 Disposable Surgical Mask with Ear Loops
• Manufacturer: Xianning Eco Medical Articles Co., Ltd.
• Date Cleared: 2021-08-19 ( 164 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

The 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 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 non-sterile.

Device Description

The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

Predicate Devices

K133070

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.

Therapeutic

No
The device is a surgical mask intended for infection control by preventing the transfer of microorganisms and particulate material, not for treating a disease or condition.

Diagnostic

No

This device is a surgical mask intended for protection and infection control, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, multi-layered surgical mask made of polypropylene materials with ear loops and a nosepiece. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware devices, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states the surgical mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
• Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
• Performance Studies: The performance studies focus on the physical properties and protective capabilities of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility). These are not studies related to the accuracy or reliability of a diagnostic test.
• Key Metrics: The key metrics are related to the mask's performance as a barrier and its safety for contact with skin, not to the results of a diagnostic test.

An In Vitro Diagnostic (IVD) device is used to examine specimens, including blood, tissue, and urine, from the human body to help detect infections, diagnose a medical condition, or prevent disease. This surgical mask does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

# Intended Use / Indications for Use
The 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 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 non-sterile.

# Product codes (comma separated list FDA assigned to the subject device)
FXX

# Device Description
The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

# 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)
**Test Methodology:** ASTM F2101- Bacterial Filtration Efficiency (BFE)
**Purpose:** To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.
**Acceptance Criteria:** >= 98% Average BFE for all samples tested
**Test Results:** 96 /96 samples passed >= 98% Average BFE (3 lots, 32 samples per lot with a lot size of 200,000 each)
 
**Test Methodology:** ASTM F2299- Particulate Filtration Efficiency
**Purpose:** To determine the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex. Spheres
**Acceptance Criteria:** >= 98% Average PFE for all samples tested
**Test Results:** 96 /96 samples passed >= 98% Average PFE (3 lots, 32 samples per lot with a lot size of 200,000 each)
 
**Test Methodology:** Differential Pressure
**Purpose:** To determine the pressure required to breathe through the final manufactured face mask
**Acceptance Criteria:** Samples must be

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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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.

August 19, 2021

Xianning Eco Medical Articles Co., Ltd. Wei Zhou General Manager No.16,Shutai Street High-Tech Industrial Zone Xianning, Hubei 437000 China

Re: K210698

Trade/Device Name: ECOMA Disposable Surgical Mask (Ear loops) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 14, 2021 Received: July 14, 2021

Dear Wei Zhou:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD 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) K210698

Device Name

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

Indications for Use (Describe)

The 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 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 non-sterile.

**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)

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Image /page/3/Picture/0 description: The image shows the word "ECOMA" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is a light color, providing contrast for the blue text.

Tel: [phone] Web:www.ecoma.com.cn Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China Fax:[phone] E-mail:[e-mail]

510(k) SUMMARY

510(k) Premarket Notification for ECOMA Level 2 Disposable Surgical Mask with Ear Loops

In accordance with the requirements set forth in Title 21 CFR §807.92

• 1. Submitter: XIANNING ECO MEDICAL ARTICLES CO., LTD. No.16, Shutai Street High-Tech Industrial Zone Xianning, China 437000
     Tel: [phone] 8018

Fax: [phone] FDA Registration Number: 3008240985

• 2. XIANNING ECO MEDICAL ARTICLES CO., LTD. Manufacturing Location: No.16, Shutai Street High-Tech Industrial Zone Xianning, China 437000 Registration Number: 3008240985
• 3. Packaging Location: Same as Manufacturing Location
• 4. Regulatory Affairs Contact: Wei Zhou General Manager Tel: [phone] 8018 Fax: [phone] Email: [e-mail] ട. Date Summary Prepared: Feb-08-2021
• 6. Name of Device: ECOMA Level 2 Disposable Surgical Mask with Ear Loops

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Tel: [phone] Web:www.ecoma.com.cn Add: No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China Fax:[phone] E-mail:[e-mail]

• 7. Trade Name: ECOMA Level 2 Disposable Surgical Mask with Ear Loops
• 8. Common/Classification Name: Surgical Mask
• 9. Regulation Number: 21 CFR §878.4040
• 10. Device Class: Class II
• Surgical Apparel 11. Regulation Name:
• 12. Product Code: FXX

13. Predicate Device: BH Medical Products Co., Ltd. Level 2 Surgical Mask with ear loops (K133070).

Device Description: The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask 14. materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

Over the counter use: Yes

Duration and type of contact: Direct contact, less than 24 hours, skin contact Single use disposable device: Yes

15. Packaging: 50 masks/box

16. Indications for Use: The 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 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 non-sterile.

17. Technological Characteristics Comparison:

• :
  For the Surgical Face Masks with Ear loops:

• Surgical Face Mask with Ear Loops

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Tel: [phone] Fax:[phone]

Web:www.ecoma.com.cn E-mail:[e-mail]

Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China

• K133070
• Submitter of 510(K)/holder: BH Medical Products Co., Ltd ●

Technological Characteristics Comparison Table (Ear loop): 18.

| Element of
Comparison | Predicted Device
K133070 | Subject Device | Comparison |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Manufacturer | BH Medical Products Co., Ltd | Xianning ECO Medical
Articles Co, Ltd. | N/A |
| Proprietary or
Model Name | Surgical Face Mask, Ear
Loops, Model
101B, 101G, 136B, 136G,
137B, 137G | Surgical Face Mask, Ear
Loops,
Model LV2001W-B | N/A |
| Intended Use | The 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
facemasks 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. | The 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
facemasks 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. | Same |
| ASTM Level | 1, 2, 3 | 2 | Similar |
| Design feature | Ear Loops and Tie on | Ear Loops | Similar |
| Mask styles | 3 flat pleated | 4 Flat pleated | Similar |
| Product
Performance
Specifications | Meet ASTM F1862-07
Meet ASTM F2101-07
Meet ASTM F2299-03
Meet MIL-M-36954C
Meet 16 CFR Part 1610 | ASTM F1862/F1862-M-17
Meet ASTM F2101-19
and EN 14683:2019
ASTM F2299/F2299M-17
Meet ASTM F2100-19
Meet 16 CFR Part 1610 | Similar
Similar
Similar
Similar
Similar |
| 16 CFR Part 1610 | Class 1 | Class 1 | similar |
| Single Use | Yes | Yes | same |
| Disposable | Yes | Yes | same |
| Non-sterile | Yes | Yes | Same |
| Material
Composition | Three-layer mask constructed
of:
Outer layer: spunbond
polypropylene
Filter layer: melt blown
polypropylene
Inner layer: spunbond
polypropylene
Binding: Spunbond
Polypropylene
Ear loops: Polyester
Nose clip: Aluminum Wire | Three-layer mask constructed
of:
Outer layer: Polypropylene
Spunbond
Filter layer: Polypropylene
Melt blown
Inner layer: Polypropylene
Spunbond
Ear loops: Spandex elastic,
polyester
Nose Piece: Malleable Iron wire
with plastic
cover/Polypropylene | Similar |
| ASTM Level | 1, 2, 3 | 2 | Similar |
| Design feature | Ear Loops and Tie on | Ear Loops | Similar |
| Mask styles | 3 flat pleated | 4 Flat pleated | Similar |
| Color | Blue, Green | Blue | Same |
| Dimensions(L*W) | 6.8" +/-0.25"x 4.2" +/-0.25" | 17.5 x 9.5 cm (+/- 0.5cm) | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Biocompatibility | The surgical mask was tested in
accordance with ISO10993 and
passed acceptance
criteria. | The surgical mask was tested
with
following standards:
• AAMI /ANSI/ ISO
10993-5:2009,
Under the testing conditions,
the subject surgical mask did
not show potential cytotoxicity
• AAMI /ANSI/ ISO
10993-10:2010,
Under the testing conditions,
the subject surgical mask did
not cause significant irritation
or sensitization
reaction to the test animals. | Same |

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11

Tel: [phone]

Web:www.ecoma.com.cn

Fax:[phone]

E-mail:[e-mail]

Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China

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Tel: [phone] Fax:[phone] Web:www.ecoma.com.cn E-mail:[e-mail]

Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China

Summary of Non-Clinical Testing (ASTM F2100 Performance Testing and Biocompatibility Testing Results) 19.

Test Methodology	Purpose	Acceptance Criteria	Test Results
ASTM F2101-
Bacterial Filtration
Efficiency (BFE)	To measure the bacterial
filtration efficiency (BFE) of
medical face mask materials,
employing a ratio of the
upstream bacterial challenge
to downstream residual
concentration to determine
filtration efficiency of medical
face mask materials.	≥ 98% Average BFE
for all samples tested	96 /96 samples passed ≥ 98% Average BFE (3 lots, 32
samples per lot with a lot size
of 200,000 each)
ASTM F2299-
Particulate
Filtration
Efficiency	To determine the Initial
Efficiency of Materials
Used in Medical Face
Masks to Penetration by
Particulates Using Latex.
Spheres	≥ 98% Average PFE
for all samples tested	96 /96 samples passed ≥ 98% Average PFE (3 lots, 32
samples per lot with a lot size
of 200,000 each)
Differential Pressure	To determine the pressure
required to breathe through
the final manufactured face
mask	Samples must be